Senior Clinical Research Monitor
Clinical Research Coordinator Job In Madison, WI
Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
We are searching for a **Senior** **Clinical Research Monitor** to join Edwards Transcatheter Mitral and Tricuspid Therapies team. As the **Senior** **Clinical Research Monitor** , you ensure trial patients' safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence. The ideal candidate will reside in Northeast region/Midwest region.
**How you'll make an impact:**
+ Field monitoring of studies and data collection for clinical trials, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements.
+ Develop and deliver technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities. Act as a mentor to new or junior level employees.
+ Provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Boards, Contract, and Training, developing process improvements.
+ Contribute to the development of clinical protocols, informed consent forms, and case report forms. Also contribute to team projects.
+ Validate investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition.
+ Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded.
+ Edit/amend informed consent documents.
**What you'll need (Required):**
+ Bachelor's Degree in related field or equivalent
+ 5 years of work experience in clinical research monitoring, with a strong focus on quality assurance, quality control, and regulatory compliance
+ Experience working in a regulated industry
+ Experience with electronic data capture
+ Ability to travel up to 75% for clinical site visits
+ Covid Vaccination
**What else we look for (Preferred):**
+ Proven experience in auditing clinical trials to ensure compliance with regulatory standards
+ Hands-on experience with database lock processes, including data verification and finalization
+ Experience with a variety of study phases (Phase I-IV) including complex trials, in pharmaceutical or medical device
+ Proficient in Monitoring Visits: Site Selection Visits (SSV), Initiation Visits (IV), Interim Monitoring Visits (IMV), Close-Out Visits (COV), Safety Follow-Up Visits, and Early Termination Visits, ensuring comprehensive oversight and adherence to study protocols
+ Knowledge of cardiovascular physiology and structural heart anatomy
+ Previous medical device Clinical Research experience in cardiology
+ Clinical research certification (ACRP or SOCRA, Clinical Coordinator/CRA certification)
+ Prior clinical research experience with Class III Medical Devices including PMA, IDE and 510(k)
+ Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are required
+ Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For Illinois (IL), the base pay range for this position is $106,000 to $140,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
**COVID Vaccination Requirement**
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
Clinical Trial Manager
Clinical Research Coordinator Job In Madison, WI
Help us change lives
At Exact Sciences, we're helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you're working to help others.
Position Overview
The Clinical Trial Manager (CTM) is responsible for supporting or leading the management, planning, execution, and closure of clinical studies. The CTM works collaboratively and cross-functionally in an exciting, fast paced environment to oversee the day-to-day operations of assigned clinical studies and ensure the successful execution of the company's clinical research plans.
This position may be remote.
Essential Duties
Include, but are not limited to, the following:
Coordinate and oversee the operational aspects of a study including planning, start-up, enrollment and close out activities ensuring that deliverables are completed on time, within budget, and in compliance with department procedures, applicable regulations and quality standards.
Prepare, review and implement study related plans and documents including project timelines, study protocols, informed consent forms (ICFs), recruitment plans, monitoring plans, study budgets, site contracts & budgets, vendor management plans and other essential clinical study documents.
Develop plans for systems and materials required to support the efficient execution of clinical studies and is responsible for effective management during the conduct of the study.
Develop, implement and maintain tools to manage, monitor and report on study health & operations, project timelines, and study finances to department management and other stakeholders.
Participate in study database development by reviewing and contributing to case report form (CRF) design, CRF completion guideline development, edit check & manual data review requirements, and participation in user acceptance testing (UAT).
Oversee sample management activities including planning, sample handling, kit supply management, sample shipping, processing, and resulting.
Develop site recruitment plans and is responsible for the identification, selection, start-up and performance monitoring of clinical research sites.
Develop study budgets and is responsible for accurately forecasting and managing study expenses. Oversee site contracting and study budget management including facilitation of site contract and budget negotiations, invoice review and approval, accrual management and maintenance of budget tracking tools.
Oversee study and site management activities such as, training, data entry & query resolution, TMF maintenance, and ensure compliance with study plans such as the study protocol, monitoring plans, and recruitment plans.
Conduct monitoring activities as needed.
Ensure the smooth and efficient closure of studies through development of plans for completion of data verification & review, planning & facilitation of database lock activities, determination of site & IRB/EC readiness for closure, statistical analysis and clinical study report development.
Participate in the identification, qualification, selection and management of vendors providing support to clinical studies.
Provide oversight and support for assigned clinical operations study team members. Leads cross-functional team meetings, ensuring study goals and priorities are clear. Professionally interacts with investigators and site staff, vendors, key opinion leaders and consultants.
Ability to identify, mitigate and manage study risks. Responsible for maintaining ongoing study audit readiness and participates in internal or regulatory authority audits.
Provide guidance and support to less experienced team members. Fosters a collaborative and knowledge-sharing environment, promoting continuous learning within the team.
Ability to provide oversight to multiple studies.
Participate or may facilitate department or project initiatives under the direction of department management or lead clinical trial manager.
Uphold company mission and values through accountability, innovation, integrity, quality and teamwork.
Support and comply with the company's Quality Management System policies and procedures.
Maintain regular and reliable attendance.
Ability to act with an inclusion mindset and model these behaviors for the organization.
Ability to work a designated schedule.
Ability to work on a mobile device, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
Ability to work on a computer and phone simultaneously.
Ability to travel 20% of working time away from work location, may include overnight/weekend travel.
Ability to attend off-site meetings and conferences as needed.
Minimum Qualifications
Bachelor's degree in the life sciences or field as outlined in the essential duties.
5+ years of experience in clinical research.
1+ year of experience of experience leading project teams through the start-up, study conduct, data management, analysis, close out and report writing of clinical studies.
Clinical monitoring experience including data review, query resolution, protocol deviation identification/tracking/trending, site initiation, site maintenance, and site closeout visits.
Experience writing, reviewing and editing protocols.
Knowledge of applicable quality standards (e.g. Good Clinical Practices (ICH/GCP), ISO 20916) and applicable local and national regulations governing clinical research.
Authorization to work in the US without sponsorship.
Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
Experience providing oversight to external vendors (e.g. CRO, central labs, call centers, DCT providers).
Preferred Qualifications
1+ year of clinical research experience with a sponsor company or CRO.
International study experience, IVDR, and GDPR implementation.
Working knowledge of the FDA submission process including, IDE, PMA and 510(k).
Experience as a study coordinator or clinical research associate.
Sample management system experience.
#LI-KB1
Salary Range:
$109,000.00 - $174,000.00The annual base salary shown is for this position located in US - WI - Madison on a full-time basis. In addition, this position is bonus eligible, and is eligible to be considered for company stock at hire and on an annual basis.
Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.
Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.
Not ready to apply? Join our Talent Community to stay updated on the latest news and opportunities at Exact Sciences.
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law. Any applicant or employee may request to view applicable portions of the company's affirmative action program.
To view the Right to Work, E-Verify Employer, and Pay Transparency notices and Federal, Federal Contractor, and State employment law posters, visit our compliance hub. The documents summarize important details of the law and provide key points that you have a right to know.
Clinical Scientist - Ultrasound
Clinical Research Coordinator Job In Madison, WI
In close partnership with Ultrasound clinical and academic research partners - as well as GE Healthcare colleagues - this position will be responsible for exploring, developing, and validating advanced imaging use and applications, ultimately expanding the translational impact of our technology solutions in clinical practice to provide precision healthcare across the globe.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
**Job Description**
**Essential Responsibilities**
+ Support collaborative academic and clinical partners (physician users of ultrasound, including cardiologists, emergency and critical care physicians, OBGYN/MFM, surgeons, and radiologists, physicists, and sonographers) in highly collaborative clinical research with emphasis on assigned key academic and clinical sites in Ultrasound
+ Become embedded in GEHC global Ultrasound R&D and Research teams to enable the advancement of strategically planned technology development and evidence with external collaborators.
+ Support adoption of new technology or clinical applications through advocacy and evidence.
+ Drive insights into GEHC R&D roadmap and evidence planning by being directly connected (feet on the ground) in key ultrasound labs (clinical and research).
+ Support utilization and impact of research deliverables by partnering with other functions (marketing, engineering, regulatory, and research).
+ Support adjustments to configuration or research tools (e.g., software, prototypes, off-line analysis) as it relates to collaborative activity with specific attention to AppAPI development.
+ Define and build out additional research functionality and features to be implemented in GEHC Ultrasound portfolio.
+ Closely connect with GEHC global modality clinical and R&D teams, explore unmet clinical and technical needs with external collaborators identify new research needs and build evidence.
+ Maintain and grow collaborator networks, increase connections between sites, and facilitate multi-site collaborations. Enable sites to strengthen their own independent research activities through providing inputs to study design, methodology, focal area, and awareness of publication landscape.
+ Support customer satisfaction through communication, observation, and escalation of site inquiries/concerns and support of educational and training services- serving as a technical product expert and prioritizing user feedback.
+ Grow technology leadership mindshare through joint co-authored or lead authored scientific publications in peer-reviewed journals.
+ Provide support in pre- and post-market evidence generation at collaborating institutions, working with functional teams (e.g. Research & Scientific Affairs, modality research, engineering) to optimize research collaborations and approach tied to GEHC Ultrasound product development needs and aligned institution interests.
+ Study new technology concepts and leverage expertise to move initiatives forward.
+ Participate in customer presentations regarding use of products for institution research purposes.
+ Assist in maturing evidence portfolio (writing journal publications/summary articles, technical documents, clinical marketing/training collaterals) and identifying unique opportunities for partnership (contributing to letters of support, research proposals, supporting identified grant submissions).
+ Continuously grow clinical and technical expertise which may include participation in local or global conferences, mentoring, providing lectures, connecting with other scientists, attending training, participating in internal development meetings, and staying abreast of new literature.
**Required Qualifications:**
+ PhD or Master's degree, or foreign degree equivalent, in Medical Imaging, Physics, Computer Science, Biomedical Engineering, or related field
+ 3 + years of experience in Ultrasound healthcare industry or research
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
\#LI-hybrid
\#LI-NV1
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
**Relocation Assistance Provided:** Yes
Clinical Research Unit Lab Specialist
Clinical Research Coordinator Job In Madison, WI
Work Schedule: 100% FTE, 40 hours per week. Shifts scheduled Monday through Friday between the hours of 7:30 AM - 4:00 PM or 8:00 AM - 4:30 PM. Hours may vary based on the needs of the clinic. Be part of something remarkable Bring your lab experience to our remarkable clinical research team. The Clinical Research Unit (CRU) is a dedicated research facility that conducts high quality clinical research that includes a sample processing laboratory.
We are seeking a Clinical Research Unit Lab Specialist to:
* Perform basic to moderately complex lab set-up and sample processing according to established protocols and procedures.
* Verify provider orders are entered for all research samples and UW Health labs required for upcoming CRU study visits.
* Receive research specimens and carefully check label and applicable paperwork for accuracy and completeness.
* Identify research kits needed for upcoming CRU visits and coordinate communication to study teams with CRU charge nurse.
* Create and maintain use of the CRU sample log on a daily basis, noting expected number of samples, samples obtained, stored, and tracking sample pick-up.
Education:
Minimum - High school diploma or equivalent
Preferred - Some post-secondary education in a healthcare or a related science field that may include course work in Medical Laboratory Technician, Cytotechnologist, Histotechnician or Medical Laboratory Scientist degree/certification.
Work Experience:
Minimum - Six months experience in lab or healthcare
Preferred - One year healthcare or lab related work experience Experience with sample collection and sample processing Experience with quality assurance and good laboratory practices
Licenses and Certifications:
Minimum -
Preferred -Medical Laboratory Technician (MLT) or equivalent
Our Commitment to Diversity, Equity, and Inclusion
UW Health is committed to being a diverse, equitable, inclusive and anti-racist workplace and is an Equal Employment Opportunity, Affirmative Action employer. Our integrity shines through in patient care interactions and our daily work practices as we work to embrace the knowledge, unique perspectives and qualities each employee and faculty member brings to work each day. Applications from Black, Indigenous and People of Color (BIPOC) individuals, LGBTQ+ and non-binary identities, women, persons with disabilities, military service members and veterans are strongly encouraged. EOE, including disability/veterans.
Eastpark Medical Center - UW Health's state-of-the-art ambulatory facility located across from East Madison Hospital on Eastpark Blvd. transforms the patient experience. It is home to many specialties, including women's complex care, adult cancer care, advanced imaging and laboratory services and innovative clinical trials.
Job Description
UW Hospital and Clinics benefits
Scientist, Clinical Trial Optimization
Clinical Research Coordinator Job In Madison, WI
_Contributes to program and study-level feasibility and operational parameters_ : Via gathering and reviewing of evidence, uses, and contributes to project program/study milestones, create site selection criteria, and establish need for patient recruitment and retention strategies and tactics. Collaborates with senior Global Technical Operations staff, CSSM to align on deliverables. (25%)
_Contributes to program and study-level recruitment and retention plan_ : initiates study-level assessment of patient recruitment needs and considers outreach and recruitment vendor strategies, in collaboration with senior
Global Technical Operations staff. May contribute to implementation plans for delivery of recruitment and retention strategies and tactics in compliance with federal and local country regulations. (25%)
_Project management of Enrollment Support Tactics:_ the
Global Technical Operations authors or manages vendor authoring of study-level enrollment support material. Includes country specific translation and delivery timelines in alignment with overall study timelines. (30%)
_Personal and Professional Development:_ Attends training and conferences in Patient recruitment and retention, feasibility and other related topics to bring greater skills and depth of knowledge to bear on the
Global Technical Operations function. (10%)
_May contribute to training, and process improvement:_ provide leadership to less experienced Global Technical Operations by demonstrating, on-the-job, the evidence based approach to clinical trial planning. Provides training, mentorship and instructions on Global Technical Operations methods and guides others re: application of informatics, simulation, and modeling. (10%)
**Impact**
Under the supervision of his/her manager, the Global Technical Operations authors and delivers Global Technical Operations contributions to assigned clinical trial teams. These contributions be used for identification, qualification, selection and preparation of sites and for recruitment and retention of patients in our company's clinical trials. The Global Technical Operations may participate in early identification of potential risks to those objectives. The Global Technical Operations may participate in developing and implementing mitigation strategies when needed. Collaborates with manager to align the operational execution plan with our Research and Development Division scorecard objectives.
**Decision Making**
Under the supervision of their management, the Global Technical Operations conducts operational analyses and planning to ensure that patient recruitment strategies and tactics identified for a program/study are practical, experienced based and cost effective to execute. In collaboration with his/her management chain, the Global Technical Operations finalizes deliverables and identifies potential areas for process improvement.
**Problem Solving**
The Global Technical Operations must have good analytical skills and be able to synthesize data and differing points of view to navigate to an evidence-based data driven solution. He/she must exhibit a developing skill set in negotiating and influencing stakeholders.
**Expertise**
The Global Technical Operations should possess a Bachelor of Science degree in medical/pharmaceutical/biological sciences with at least 3 years of career experience including 2 years in the conduct of clinical trials and some knowledge in business process analytics and continuous improvement. Desired skills include formal education and or training in medical, marketing, and/or communication. An ability to analyze clinical data and synthesize medical evidence into a plan is a strength. The incumbent needs to have demonstrated administrative and project management abilities in a relevant clinical development setting. The incumbent must have excellent interpersonal and communication skills preferably practiced in an international clinical research environment.
**Leadership**
The Global Technical Operations must be able to communicate and express ideas clearly, orally and in writing, to contribute to operational parameters, recruitment and retention plans and other key Global Technical Operations deliverables. He/she may represent Global Technical Operations , with support from management and GO TA lead, at cross functional review meetings such as LDRC/EDRC TA DRC, FORce, Operational Review.
**Influence / Liaison**
Under the supervision of their manager, the Global Technical Operations will be a representative to support to other CTT functional areas in the education and methodology of feasibility and patient recruitment science and a trusted resource to operational field personnel implementing and managing recruitment and retention tactics at the site level. The Global Technical Operations outputs for which a Global Technical Operations is responsible drive Clinical supply planning, timing and feasibility assessment of clinical programs and studies, and LDRC contract dates.
**Qualifications, Skills & Experience**
+ Bachelor's Degree (Life-science related)
+ 2 years of clinical trial related experience (Entry level to function with previous experience in the conduct of clinical trials required)
**Functional Area**
Clinical Research
**Job Family**
Clinical Research Generic
**Management or Individual Contributor**
Individual Contributor
**Geographical Scope**
\#eligibleforerp
ResearchandDevelopmentGCTO
VETJOBS
EBRG
Current Employees apply HERE (*****************************************************
Current Contingent Workers apply HERE (*****************************************************
**US and Puerto Rico Residents Only:**
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (******************************************************************************************
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (**********************************************
**U.S. Hybrid Work Model**
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
No relocation
**VISA Sponsorship:**
No
**Travel Requirements:**
10%
**Flexible Work Arrangements:**
Remote
**Shift:**
Not Indicated
**Valid Driving License:**
No
**Hazardous Material(s):**
N/A
**Job Posting End Date:**
04/23/2025
***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**
**Requisition ID:** R346184
Clinical Scientist / Innovative Trial Design
Clinical Research Coordinator Job In Madison, WI
We are looking for a: Clinical Science Trial Innovation Manager to join our global Clinical Science team. The role is based in Madison, Wisconsin or Wilmington, Delaware reporting directly to the Chief Medical Officer. About IFF: IFF is a Fortune 500 bioscience leader in enzyme technologies, probiotics & cultures, and biotech solutions that improve the health of people, animals, and our planet.
Job Purpose: The clinical science organization is responsible for generating the evidence to substantiate the safety and benefits of the products in our pipeline. The purpose of this role is to deliver enterprise-wide clinical trial design leadership at IFF.
Key Responsibilities include but are not limited to:
* Contribute to the development and timely execution of the Clinical Science strategy.
* Develop and design clinical trials with a focus on innovative and novel approaches to demonstrate the benefit and safety of products within the IFF portfolio and pipeline.
* Lead the development of clinical trial protocols when required, ensuring they meet scientific, regulatory, and ethical standards.
* Apply and implement novel trial designs to enhance the efficiency and effectiveness of clinical trials.
* Establish relationships and engage with key stakeholders, including customers, key opinion leaders, scientific societies, and professional trade organizations to advance clinical development and IFF scientific leadership.
* Identify opportunities for continuous improvement in trial design and execution.
* Assist in the preparation and review of regulatory submissions related to clinical trials.
* Monitor and understand the competitive landscape and engage in external scientific environment, bringing forth insights that inform clinical and/or R&D direction.
* Partner with clinical innovation teams to create publication plan, collaborating in data interpretation and key message development.
* Conduct all work in accordance with company ethics, regulatory, quality & safety standards, and SOPs.
Education and Experience
Minimum level of education: Advanced scientific degree preferred (MD, PhD, RD or equivalent) in medical, biological or pharmaceutical sciences.
Experience: Minimum 3 years of experience in clinical development or similar role with clinical trials within consumer healthcare, pharma or OTC required.
Job Skills
* Excellent verbal and written communication skills
* Translational mindset with experience in developing human clinical trials from pre-clinical data and models
* Background in statistics preferred but not required
* Competency in regional clinical trial regulatory requirements
* Knowledge in clinical applications of microbiome-based products, botanicals and/or consumer healthcare ingredients in the areas of digestive, immune and metabolic health
* Collaborative work style, able to excel in cross-functional teams
* Comfortable challenging opinions and listening to alternative views
* Flexibility in terms of working hours since you will be working with individuals from different time zones.
* Domestic and international travel may be required to support the function of the team.
* Salary and rank commensurate on candidate experience.
We are a global leader in taste, scent, and nutrition, offering our customers a broader range of natural solutions and accelerating our growth strategy. At IFF, we believe that your uniqueness unleashes our potential. We value the diverse mosaic of the ethnicity, national origin, race, age, sex, or veteran status. We strive for an inclusive workplace that allows each of our colleagues to bring their authentic self to work regardless of their religion, gender identity & expression, sexual orientation, or disability.
Visit IFF.com/careers/workplace-diversity-and-inclusion to learn more
Clinical Scientist, Immunology
Clinical Research Coordinator Job In Madison, WI
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
The Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs.
Position Summary / Objective
* Will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct
* May serve as Clinical Trial Lead for one or more trials
* May lead or support trial level activities for one or more trials with the necessary supervision
* May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members
Position Responsibilities
* Collaborate and liaise with external partners (e.g., KOLs)
* Seek out and enact best practices with instruction
* Provide regular and timely updates to manager/management as requested
* Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required
* Conduct literature review
* Submit clinical documents to TMF
* Develop site and CRA training materials and present these at SIVs and Investigator meetings
* Review clinical narratives
* Monitor clinical data for specific trends
* Develop Data Review Plan in collaboration with Data Management
* Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
* Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.)
Degree Requirements
Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred). Appropriate for new entrance to pharma (post fellowship/ new to industry)
Experience Requirements
* Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
* Ability to understand assigned protocol(s) and their requirements
* Basic knowledge skills to support program-specific data review and trend identification
* Intermediate medical writing skills and medical terminology
* Basic planning/project management skills (develop short range plans that are realistic and effective)
Travel Required
Domestic and International travel may be required.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: *********************************************
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Clinical Research Coordinator
Clinical Research Coordinator Job In Madison, WI
UW Clinical Trials Institute (CTI) is a partnership between the University of Wisconsin School of Medicine and Public Health (SMPH) and UW Health. It supports clinical research professionals, investigators and participants to advance discovery and research in the prevention, detection, and treatment of disease to help improve the health of individuals, families, and communities across Wisconsin and beyond. Our exceptionally talented workforce provides care, support, and provide information to clinical trials participants; resources, training, and guidance to research professionals; and opportunities for industry partners to advance groundbreaking medical research.
The CTI has an exciting opportunity for a full-time, clinical research coordinator to join our growing team. The ideal candidate is intrinsically motivated, detailed oriented, an enthusiastic problem solver, and works well in a multi-disciplinary team with minimal supervision to achieve a common goal. This role directly interacts with current and prospective participants of all ages and backgrounds, so the successful applicant is a clear, compassionate oral and written communicator with a strong customer service attitude. Additional responsibilities of the role include executing the procedures of the research protocol, safeguarding the integrity of study data, and actively participating in the screening, recruitment, and retention of our clinical trial participants, so strong organizational skills is imperative. The ideal candidate will have strong Microsoft applications and medical terminology understanding.
The Clinical Research Coordinator who will work in collegial fashion with principal investigators, research coordinators, administrators, and institutional collaborators on clinical research studies. This role includes management and execution of research studies, management of patient and laboratory data, and the screening, recruitment, and retention of clinical trial participants.
This is an on-site position with standard business hours expected during the workweek. A remote day will be given after the probation period. However, flexibility is essential, as occasionally early mornings, evenings, or weekends may be required to accommodate the schedules of the research participants. Additionally, the role may involve travel between research sites within the metro Madison area, so they should have reliable transportation or be willing to use public transportation. If you are ready to make a meaningful impact in the field of clinical research, we encourage you to apply today!
Coordinators are required to complete the following training: HIPAA, human subjects protection training, biosafety shipping and laboratory safety.
Responsibilities:
Clinical Research Coordinator I (RE015)
Clinical Research Coordinator II (RE016)
Institutional Statement on Diversity:
Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals.
The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world.
For more information on diversity and inclusion on campus, please visit: Diversity and Inclusion
Education:
Preferred
Bachelor's Degree
Preferred focus in health or science related field
Qualifications:
Clinical Research Coordinator I - Preferred Qualifications
* At least 1-year previous research experience.
* Previous experience with basic clinical assessments including phlebotomy.
* Previous experience with research applications used in the UW CTI: OnCore, eBinders, HealthLink, etc.
Clinical Research Coordinator II - Required Qualifications:
* At least 2 years of prior clinical research coordination experience.
* Current ACRP or SoCRA Certification or ability to become certified within 6 months of hire.
Clinical Research Coordinator II - Preferred Qualificaitons:
* Previous experience with basic clinical assessments including phlebotomy.
* Previous experience with research applications used in the UW CTI: OnCore, eBinders (Florence), Advarra Payments, EPIC, etc.
* Experience with training new staff.
License/Certification:
Required
Drivers License - Valid and Meets UW Risk Management Standards
Travel to multiple sites required. Must provide a valid driver's license. Employees may use their own transportation or receive approval for University Car Fleet usage. Employment is conditional pending the results of a Pre-hire Driver Authorization Check. See ********************************************************************************************************************************* (click on Become an authorized driver then click on Required criteria).
Work Type:
Full Time: 100%
It is anticipated this position requires work be performed in-person, onsite, at a designated campus work location.
Appointment Type, Duration:
Ongoing/Renewable
Salary:
Minimum $47,000 ANNUAL (12 months)
Depending on Qualifications
The starting salary for each title is as follows but is negotiable based on experience and qualifications.
* Clinical Research Coordinator I: $47,000
* Clinical Research Coordinator II: $51,000
Additional Information:
Applicants for this position will be considered for the titles listed in this posting. The title is determined by the experience and qualifications of the finalist.
University sponsorship is not available for this position, including transfers of sponsorship and TN visas. The selected applicant will be responsible for ensuring their continuous eligibility to work in the United States (i.e. a citizen or national of the United States, a lawful permanent resident, a foreign national authorized to work in the United States without the need of an employer sponsorship) on or before the effective date of appointment. This position is an ongoing position that will require continuous work eligibility. If you are selected for this position you must provide proof of work authorization and eligibility to work.
This position has been identified as a position of trust with access to vulnerable populations. The selected candidate will be required to pass an initial caregiver check to be eligible for employment under the Wisconsin Caregiver Law and every four years.
How to Apply:
To apply for this position, please click on the "Apply Now" button. You will be asked to upload a current resume/CV and a cover letter briefly describing your qualifications and experience.
Contact:
Jennifer Wilkie
****************
************
Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.
Official Title:
Clin Res Coord I(RE015) or Clin Res Coord II(RE016)
Department(s):
A53-MEDICAL SCHOOL/CLINICAL RESEARCH
Employment Class:
Academic Staff-Renewable
Job Number:
313485-AS
The University of Wisconsin-Madison is an Equal Opportunity and Affirmative Action Employer.
Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. We promote excellence through diversity and encourage all qualified individuals to apply. For more information regarding applicant and employee rights and to view federal and state required postings, click here
If you need to request an accommodation because of a disability, you can find information about how to make a request at the following website: ******************************************************************************************
Employment may require a criminal background check. It may also require you and your references to answer questions regarding sexual violence and sexual harassment.
The University of Wisconsin System will not reveal the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7).
The Annual Security and Fire Safety Report contains current campus safety and disciplinary policies, crime statistics for the previous 3 calendar years, and on-campus student housing fire safety policies and fire statistics for the previous 3 calendar years. UW-Madison will provide a paper copy upon request; please contact the University of Wisconsin Police Department.
Clinical Research Coordinator
Clinical Research Coordinator Job In Madison, WI
MUST HAVE At least 1 year of experience in Hematology/Oncology The Clinical Research Coordinator coordinates clinical research studies by performing a variety of tasks and activities. This role involves recruiting, screening, selecting, determining eligibility, and enrolling study participants while ensuring subjects follow the research protocol. The coordinator also develops study-related documents, navigates resources, and identifies issues needing escalation. Additionally, the role contributes to the development of new team and unit processes, procedures, staff, and tools.
Responsibilities
* Recruit, screen, select, determine eligibility, and enroll trial participants. Collect complex information, perform medical assessments, and answer varied questions under the supervision of a medically licensed professional. Perform medical assessments after completing required training/certification, such as collecting vital signs, obtaining weight, and performing phlebotomy.
* Manage research workflow components, collect, prepare, process, and submit participant data and samples to appropriate entities, adhering to research protocols.
* Identify work unit resource needs and manage supply and equipment inventory levels.
* Serve as a main point of contact for clinical research participants, providing information regarding research procedures, expectations, and informational inquiries. Ensure participants follow the research protocol and alert the Principal Investigator of any issues.
* Perform quality checks.
* Identify resource needs and develop clinical research documents, such as job aids, tools, processes, procedures, and training materials. Contribute to the development of protocols.
* Assist with training of staff.
Essential Skills
* Clinical research experience
* Experience in clinical trials
* Patient recruitment skills
* Hematology and Oncology experience
Additional Skills & Qualifications
* Local to Madison, Wisconsin
Work Environment
The work environment involves coordinating clinical research studies and interacting with participants. It requires managing various workflow components, ensuring protocol adherence, and maintaining supply and equipment inventory levels. The role also includes performing medical assessments and serving as a point of contact for participants, all while working under the supervision of medically licensed professionals.
Pay and Benefits
The pay range for this position is $22.00 - $27.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
* Medical, dental & vision
* Critical Illness, Accident, and Hospital
* 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
* Life Insurance (Voluntary Life & AD&D for the employee and dependents)
* Short and long-term disability
* Health Spending Account (HSA)
* Transportation benefits
* Employee Assistance Program
* Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Madison,WI.
Application Deadline
This position is anticipated to close on Apr 29, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
* Hiring diverse talent
* Maintaining an inclusive environment through persistent self-reflection
* Building a culture of care, engagement, and recognition with clear outcomes
* Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Clinical Sample Analysis Associate II
Clinical Research Coordinator Job 7 miles from Madison
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials
Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
Our PPD Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
Discover Impactful Work:
As a Sample Coordinator, you will perform a variety of sample and standard handling tasks in support of the laboratory. You will follow established SOPs and responds to requests from laboratory staff with minimal direction. You will assist laboratory staff in following sample handling procedures and implements these procedures as necessary.
A day in the Life:
* Performs a variety of sample and standard tasks (receipt, check-in, login, labeling, launching, inventory, transport, check-out, etc. May participate in physical return and disposal of materials in support of the laboratory.
* Communicates status of samples / standards to appropriate laboratory staff.
* Guides and advises laboratory staff in sample / standard procedures.
* Completes investigation and deviation forms as necessary, and determines appropriate CAPAs.
* Reviews and provides feedback on laboratory requests, ensuring compliance with applicable SOPs.
* Trains on SOPs, regulatory guidelines, and storage requirements. Responds to environmental unit alarms and participates in on-call responsibilities.
* Performs work assignments accurately and in a timely and safe manner.
Keys to Success:
Education
* High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification Technical positions may require a certificate
Experience
* Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years) or equivalent combination of education, training, & experience.
* Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.
Knowledge, Skills, Abilities
* Basic knowledge of inventory flow and control
* Knowledge of laboratory and regulatory requirements (documentation, sample storage)
* Ability to write/review SOPs and process improvement outlines
* Familiarity with Microsoft Office including Word and Excel
* Good written and oral communication skills
* Effective time management and project management skills
* Problem solving/troubleshooting abilities
* Ability to work in a collaborative team environment
Work Environment
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
* Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
* Able to work upright and stationary and/or standing for typical working hours.
* Able to lift and move objects of 15 to 40 pounds
* Able to work in non-traditional work environments.
* Able to use and learn standard office equipment and technology with proficiency.
* May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
* Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
* Exposure to fluctuating and/or extreme temperatures on rare occasions
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Clinical Research Coordinator, Oncology Program
Clinical Research Coordinator Job 33 miles from Madison
* Janesville, Wisconsin * Full-time, Benefits Eligible Experience a rewarding and fulfilling career with Mercyhealth. Mercyhealth is committed to offering our partners a best place to work. Our unique workplace Culture of Excellence is built upon:
* Employee engagement, empowerment and growth
* Teamwork toward our common goal - providing exceptional health care services with a passion for making lives better
* An atmosphere of caring and quality that cascades throughout the organization
The primary function of the Clinical Research Coordinator (CRC) is to coordinate the conduct of clinical research studies in a clinic/hospital setting with an emphasis on the screening, enrollment, and monitoring of research patients. Performs other duties as assigned.
Responsibilities
Essential Duties and Responsibilities
* Recruit, screen, enroll, obtain consent from study participants and provide patient education as necessary.
* Prepare IRB documents and reports; ensure compliance with relevant IRB policies and regulatory agency requirements. (i.e.: continuing reviews or study updates)
* Organize and maintain study documents including data collection forms, informed consent forms, and regulatory documents. Submitting accurate and timely data.
* Assist with the collection of patient samples, including blood, urine, and saliva; process and prepare specimens (centrifuge, pipette as required).
* Maintain patient calendars to ensure protocol adherence
* Shipping of specimens
* Patient coordination for research protocols including arranging necessary appointments and procedures, working collaboratively with other departments and institutions, and maintaining contact with study participants.
* Long-term follow up of study participants
* Data submission and monthly/quarterly reports
* Work with billing department for billing of study patients on a clinical trial
* Maintain investigational brochures
* Track and report all adverse events
* Collaborate on development of program materials such as marketing and education
Culture of Excellence Behavior Expectations
To perform the job successfully, an individual should demonstrate the following behavior expectations:
Quality - Follows policies and procedures; adapts to and manages changes in the environment; Demonstrates accuracy and thoroughness giving attention to details; Looks for ways to improve and promote quality; Applies feedback to improve performance; Manages time and prioritizes effectively to achieve organizational goals.
Service - Responds promptly to requests for service and assistance; Follows the Mercyhealth Critical Moments of service; Meets commitments; Abides by MH confidentiality and security agreement; Shows respect and sensitivity for cultural differences; and effectively communicates information to partners; Thinks system wide regarding processes and functions.
Partnering - Shows commitment to the Mission of Mercyhealth and Culture of Excellence through all words and actions; Exhibits objectivity and openness to other's views; Demonstrates a high level of participation and engagement in day-to-day work; Gives and welcomes feedback; Generates suggestions for improving work: Embraces teamwork, supports and encourages positive change while giving value to individuals.
Cost - Conserves organization resources; Understands fiscal responsibility; Works within approved budget; Develops and implements cost saving measures; contributes to profits and revenue.
Education and Experience
Minimum Required Education: Associate's Degree
Clinical research experience preferred.
Certification and Licensure
Other certification(s) per unit requirements
Certified Clinical Research Professional or Certified Clinical Research Coordinator (ACRP or SoCRA), preferred.
Skills and Abilities
Technical Skills - Pursues training and development opportunities; Strives to continuously build knowledge and skills.
Knowledge of biology, chemistry, mathematics, documentation, and records management
Data utilization, complex problem solving, critical thinking, resource management, writing skills, strong interpersonal communication skills, detailed oriented, and able to multi-task
Proficient in Microsoft Office Word and Excel, electronic health systems and databases used in research environment, or have a willingness to learn and demonstrate proficiency within six months of hire
Special Physical Demands
The Special Physical Demands are considered Essential Job Functions of the position with or without reasonable accommodations.
While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is frequently required to use hands to finger, handle, or feel. The employee is frequently required to stand; walk; reach with hands. Specific vision abilities required by this job include close vision and ability to adjust focus.
Level of Supervision
N/A
Supervises
This position has no supervisory responsibilities.
Benefits
Mercyhealth offers a generous total rewards package to eligible employees including, but not limited to:
* Comprehensive Benefits Package: Mercyhealth offers a retirement plan with competitive matching contribution, comprehensive medical, dental, and vision insurance options, life and disability coverage, access to flexible spending plans, and a variety of other discounted voluntary benefit options.
* Competitive Compensation: Mercyhealth offers market competitive rates of pay and participates in various shift differential and special pay incentive programs.
* Paid Time Off: Mercyhealth offers a generous paid time off plan, which increases with milestone anniversaries, to allow employees the opportunity for a great work-life balance.
* Career Advancement: Mercyhealth offers a number of educational assistance programs and career ladders to support employees in their educational journey and advancement within Mercyhealth.
* Employee Wellbeing: Mercyhealth has a focus on wellbeing for employees across the organization and offers a number of tools and resources, such as an employer-sponsored health risk assessment and a Wellbeing mobile application, to assist employees on their wellbeing journey.
* Additional Benefits: Mercyhealth employees have access to our internal and external employee assistance programs, employee-only discount packages, paid parental and caregiver leaves, on-demand pay, special payment programs for patient services, and financial education to help with retirement planning.
Travel Per Diem Mobile Research Nurse
Clinical Research Coordinator Job In Madison, WI
Science 37's Nursing Solutions Group brings together expert nurses who share a passion for organizing, planning and implementing mobile clinical nurse services to participants in clinical trials. Science 37's extraordinary work environment allows continuous collaboration between clinicians, clinical researchers, patient recruitment specialists, data managers and technology developers. The Nursing Solutions Group is involved throughout the trial life cycle, from protocol development and feasibility analysis to clinical trial implementation and closeout.
The Per Diem Mobile Research Nurse is a Registered Nurse who will work per diem and has experience across multiple therapeutic areas with the ability to work independently and integrate well with the Nursing Solutions Group. With interest/expertise in Science 37's decentralized model of care delivery, the Mobile Research Nurse will perform delivery of care to participants as well as collaborate with brick and mortar sites, if indicated, for shared clinical trial implementation. The Mobile Research Nurse ensures the professional delivery of patient care in compliance with all federal and state regulations, Good Clinical Practice, and Standard Operating Procedures.
*This is a travel role that requires on-site visits to participants homes.
Duties for this position include but are not limited to:
Participate and provide research nurse services to qualified study participants at home
Apply clinical research and nursing practices to develop solutions to complex problems
Collaborate with Lead and Per Diem Mobile Research Nurses on solutioning, education, and resource support
Participate in activities that will further the operational development of Science 37 nursing service delivery
Develop relationships with study team members and serve as the subject matter expert (SME) on all nursing processes
Other duties as assigned as the needs of Science 37 evolve and change
This position has the following qualifications:
BSN degree preferred
Full Covid Vaccination strongly preferred. Science 37 follows CDC guidelines for vaccination recommendations and such guidelines are subject to change.
Active RN licensure in home state as well as eligibility for Compact Licensure required
Minimum 2+ years clinical/research experience preferred
Basic Life Support (BLS) Certification
Maintain a positive reflection of the company by representation in participant's homes or in clinic settings
Travel and availability qualifications are as follows:
1-2 days minimum a week dedicated to support Science 37's study visits
Weekday/night availability required
Must be willing to travel to a participants homes
Active Driver's License
Science 37 is looking for people with the following skills and competencies:
BSN degree preferred
Active RN licensure in home state as well as eligibility for Compact Licensure required
Minimum 2+ years clinical/research experience preferred
Basic Life Support (BLS) Certification
Active Driver's License
Weekday/night availability required
Maintain a positive reflection of the company by representation in participant's homes or in clinic settings
Up to 100% travel, as needed, for study participant visits, project team meetings, and other professional meetings/conferences as needed
Ability to obtain nursing license in multiple states based on study needs
Physical ability to perform nursing tasks and lift equipment up to 15 kg in weight
Access to a reliable vehicle to perform study participant visits and transport equipment
Ability to drive to local and/or remote locations to perform study participant visits
Ability to use technology effectively and appropriately for study participant assessments and documentation including but not limited to study participant care equipment, laptop computers, communication devices and tablets
Ability to communicate in English (both verbal and written)
There is minimal supervision for this position, with individuals reporting to the Manager, Nursing Solutions Group.
Compensation varies based on location and work being performed. The starting pay range for a candidate selected for this position is generally within the range of $50-55 per hour. Employees may be eligible for additional discretionary bonuses and commissions. The successful candidate's actual pay will also be based on qualifications and experience, so the actual starting pay may be above or below this range.
Science 37 is an equal opportunity employer.
We are committed to creating a diverse environment and is an equal opportunity employer. All qualified applicants receive consideration for employment without regard to age, race, ethnicity (including but not limited to hair texture and protected hairstyles), ancestry, color, sex, national origin, sexual orientation, gender, gender identity, gender expression, transgender status, religious creed, physical or mental disability (including actual or perceived disability), medical condition (including HIV/AIDS), pregnancy, perceived pregnancy and pregnancy related conditions, genetic information, marital status, political affiliation or activities, status as a victim of domestic violence, assault, or stalking, veteran status or participation in the uniformed military services of the United States, including the National Guard, or any other basis prohibited by applicable law.
Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed.
Submit your resume to apply!
To learn about Science 37's privacy practices including compliance with applicable privacy laws, please click here
Faculty Clinical Coordinator
Clinical Research Coordinator Job In Madison, WI
To participate in a remote work arrangement, employees must reside in the United States. No remote work arrangement will be considered for working from outside the United States. If you are a current employee, faculty or adjunct instructor at Herzing University (not a Contractor or temporary employee through a staffing agency), please click here to log in to UltiPro/UKG and then navigate to Menu > Myself > My Company > View Opportunities to apply using the internal application process.
The Faculty Clinical Coordinator will ensure that all assigned faculty meet the credentialing requirements of assigned facilities and that all required paperwork is submitted to the clinical facilities within the required time frame. The coordinator implements and teaches an orientation program for all clinical faculty to ensure that program outcomes are being met. The coordinator documents that the site is meeting accreditation standards at least once per clinical rotation through a site visit or other communication means. Faculty observations will be conducted and documented as appropriate per accreditation requirements.
Requirements:
* Hold a Graduate degree in nursing.
* Hold an unemcumbered RN nursing license.
* Hold a WI Compact license or have the ability to obtain.
* Be proficient with Microsoft Office Suite and internet applications, as well as, be proficient with other technologies currently used in clinical settings.
Preferred:
* Experience supervising faculty within a clinical setting.
* Experience teaching nursing students.
* Leadership experience
PAY:
Compensation is determined based on the qualifications, experience, and circumstances of each hire. It is uncommon for new employees to start near the top of the salary range. We offer a comprehensive benefits package, including a tuition waiver and reimbursement program, health insurance, paid time off, and a retirement savings plan with company match. The salary range for this position is $81,800 to 115,800.
Click Here to learn more about careers at Herzing University.
Herzing University is committed to providing a diverse environment and is dedicated to fostering a culture and atmosphere of mutual respect. It provides an inclusive and collegial community where individuals are valued, heard and empowered to contribute to the effectiveness of the institution.
It is the university's practice to recruit and hire without discrimination because of skin color, gender, religion, LGBTQi2+ status, disability status, age, country of birth, veteran status, or any other status protected by law. ***************************************
Herzing University prohibits sex-based discrimination in any education program or activity that it operates. Individuals may report concerns or questions to the Title IX Coordinator. The notice of nondiscrimination is located at *********************************
Clinical Associate
Clinical Research Coordinator Job In Madison, WI
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Clinical Associate
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:
* Career development with an international company where you can grow the career you dream of.
* Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
* An excellent retirement savings plan with a high employer contribution
* Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
* A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
* A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.
What You'll Work On
Working under general direction, provides engineering, sales, educational and technical support in response to field inquiries from physicians, health care professionals, patients, and field sales staff, involving EP products. Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises independent judgment in planning, organizing and performing work; monitors performance and reports status to manager.
* Acts as a clinical interface between the medical community and the business.
* Demonstrates ability to build and sustain credible business relationships with customers and shares product expertise accordingly.
* Provides engineering, sales, education and clinical support in response to field inquiries on as-needed basis. Demonstrates a thorough command of all EP products, related product and technical knowledge, trends and players.
* Develops, leads and/or facilitates trainings and other programs on EP products to healthcare professionals.
* Provides insight, guidance, and feedback to management on market feedback and components of next generation of products.
* Provides regional EP procedural case coverage.
* Provides additional back-up support to EP Sales Representatives in the following areas:
* Sales support;
* Regional training seminars;
* Clinical studies/data collection;
* Trouble Shooting; and,
* New product in-service training to physicians, nurses and sales representatives.
* Continuously develops engineering, sales and technical skills relative to the overall Arrhythmia Management strategy, including learning opportunities via Sr. Sales personnel and management.
* Assists Training and Education departments with advanced educational seminars, and the preparation of educational materials.
* Assists Sales with advanced product demonstrations to visiting physicians and sales personnel.
* Remains current on developments in field(s) of expertise, regulatory requirements, and a good working knowledge of company and competitor products, markets, and objectives as well as industry trends.
* Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.
* Performs related functions and responsibilities, on occasion, as assigned.
Required Qualifications
* Bachelors Degree or equivalent experience.
* Verification that you will satisfy all vendor credentialing requirements, which may include vaccination for COVID-19. If you require a medical or religious accommodation from these requirements or if you would like to understand more about these requirements, please advise HR so that we can provide additional information and if needed, we can explore any needed accommodation(s).
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: **********************
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at *************** on Facebook at ************************ and on Twitter @AbbottNews.
The base pay for this position is $50,000.00 - $100,000.00. In specific locations, the pay range may vary from the range posted.
Associate Clinical Trial Manager
Clinical Research Coordinator Job In Madison, WI
Help us change lives
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Position Overview
The Associate Clinical Trial Manager (ACTM) is responsible for supporting the management, planning, execution, and closure of clinical studies. The ACTM works collaboratively and cross-functionally in an exciting, fast paced environment to support the day-to-day operations of assigned clinical studies and ensure the successful execution of the company's clinical research plans.
This position may be remote.
Essential Duties
Include, but are not limited to, the following:
Support the coordination and management of operational aspects of a study including planning, start-up, enrollment and close out activities ensuring that deliverables are completed on time and in compliance with department procedures, applicable regulations and quality standards.
Participate in the preparation, review and implementation of study related plans and documents including project timelines, study protocols, informed consent forms (ICFs), recruitment plans, monitoring plans, vendor management plans and other essential clinical study documents.
Support planning and management of systems and materials required to support the execution of clinical studies.
Maintain tools to manage, monitor and report on study health & operations, project timelines, and study finances to department management.
Support study database development by reviewing and contributing to case report form (CRF) design, user acceptance testing (UAT), and CRF completion guideline development.
Support sample management activities including planning, sample handling, kit supply management, sample shipping, sample processing, and resulting.
Support the identification, selection, start-up and performance monitoring of clinical research sites.
Support site contracting and study budget management including facilitation of site contract and budget negotiations, invoice review and approval, accrual management and maintenance of budget tracking tools.
Oversee study and site management activities such as, training, data entry & query resolution, TMF maintenance, and ensures compliance with study plans such as the study protocol, monitoring plans, and recruitment plans.
Conduct monitoring activities as needed.
Assist in the closure of studies including planning & facilitation of database lock, site & IRB/EC closure, statistical analysis and clinical study report development.
Support the management and oversight of vendors providing support to clinical studies.
Provide proactive communication, coordination, and support to sites and members of the cross-functional study team. Actively participate in various team meetings. Interact with investigators and site staff, vendors, key opinion leaders and consultants.
Support ongoing study audit readiness and participate in internal or regulatory authority audits.
Provide guidance and support to less experienced team members.
Participate or may facilitate department or project initiatives under the direction of management or a lead clinical trial manager.
Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
Support and comply with the company's Quality Management System policies and procedures.
Maintain regular and reliable attendance.
Ability to act with an inclusion mindset and model these behaviors for the organization.
Ability to work designated schedule.
Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
Ability to work on a computer and phone simultaneously.
Ability to travel 10% of working time away from work location, may include overnight/weekend travel.
Ability to attend off-site meetings and conferences as needed.
Minimum Qualifications
Bachelor's Degree in Life Sciences or field as outlined in the essential duties.
3+ years of experience in clinical research.
Clinical monitoring experience or oversight including data review, query resolution, protocol deviation identification/tracking/trending, site initiation, site maintenance, and site closeout visits.
Experience writing, reviewing and editing protocols.
Knowledge of applicable quality standards (e.g. Good Clinical Practices (ICH/GCP), ISO 20916) and applicable local and national regulations governing clinical research.
Proficiency in Microsoft Office programs, such as: Word, Excel, PowerPoint, Outlook, Teams, SharePoint, or MS Project.
Demonstrated ability to perform the essential duties of the position with or without accommodation.
Authorization to work in the United States without sponsorship.
Preferred Qualifications
Experience participating in the qualification and management of external vendors (e.g. CRO, central labs, call centers, Decentralized Clinical Trial (DCT) providers)
Experience contributing to project teams through the start-up, study conduct, and data management.
International study experience, IVDR, and GDPR implementation
Working knowledge of the FDA submission process including IDE, PMA, and 510(k).
Experience as a study coordinator or clinical research associate.
Sample management system experience.
#LI-SH1
Salary Range:
$67,000.00 - $109,000.00The annual base salary shown is a national range for this position on a full-time basis and may differ by hiring location. In addition, this position is bonus eligible, and is eligible to be considered for company stock at hire and on an annual basis.
Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.
Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.
Not ready to apply? Join our Talent Community to stay updated on the latest news and opportunities at Exact Sciences.
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law. Any applicant or employee may request to view applicable portions of the company's affirmative action program.
To view the Right to Work, E-Verify Employer, and Pay Transparency notices and Federal, Federal Contractor, and State employment law posters, visit our compliance hub. The documents summarize important details of the law and provide key points that you have a right to know.
Clinical Research Study Coordinator
Clinical Research Coordinator Job In Madison, WI
A Clinical Research Study Coordinator is needed to work in Dr. Cynthia Carlsson's group to coordinate Alzheimer's Clinical Trials Consortium (ACTC) funded UW clinical trials, as well as VA-based Alzheimer's prevention clinical trials. The qualified candidate will be responsible for study coordination, strict adherence to study protocol and regulatory requirements, recruitment, screening and interviewing of research participants, scheduling of research appointments, data collection, organization and maintenance of research records, collection of blood samples, and arranging for CSF sample collection and MRI and PET imaging appointments, implementing study procedures, sample management, storage, and shipping, administration and scoring of specialized neuropsychological tests and questionnaires, management of accurate data collection and data entry, monitoring of study drug compliance, tracking and reporting study enrollment and study completion, and tracking and reporting adverse events.
A successful Clinical Research Study Coordinator will establish regular communication with enrolled participants to maintain study schedules and appointments and ensure that all research protocols and regulatory requirements are followed.
Additional duties include (but are not limited to) community outreach and tracking potential participants, acting as a liaison between community referrals and the research program, working closely and proactively with operational teams to ensure that the laboratory, pharmacy, and nursing units are aware of study procedures, and submitting and processing participant payments and mileage reimbursement. The Clinical Research Study Coordinator will also cross-train on other clinical studies in the Carlsson group and serve as a back-up coordinator for these studies.
The Wisconsin Alzheimer's Disease Research Center (ADRC) conducts research in the field of aging and dementia, and seeks to establish effective prevention, diagnosis and treatment of Alzheimer's Disease (AD). The ADRC actively partners with individuals from diverse underrepresented communities to identify and address health disparities in diagnosis and management of dementia.
Responsibilities:
Coordinates clinical research studies, performing a variety of tasks and activities. Recruits, screens, selects, determines eligibility, and enrolls study participants and ensures subjects follow the research protocol. Develops study-related documents. Applies expertise, knowledge, and skills to a broad range of different types of clinical studies, navigates resources, and identifies issues needing escalation. Contributes to development of new team and unit processes, procedures, staff, and tools.
* 50% Schedules logistics, determines workflows, and secures resources for clinical research trials
* 10% Recruits, screens, selects, determines eligibility and enrolls trial participants, collects more complex information, performs medical assessments, and answers varied questions under supervision of a medically licensed professional. Performs medical assessments after completion of required training/certification, such as collecting vital signs, obtaining weight, and performing phlebotomy
* 5% Manages research workflow components, collects, prepares, processes, and submits participant data and samples to appropriate entities, adhering to research protocols
* 5% Identifies work unit resources needs and manages supply and equipment inventory levels
* 5% Serves as a main point of contact for clinical research participants, providing information regarding research procedures, expectations, and informational inquiries. Ensures participants follow the research protocol and alerts Principal Investigator of issues
* 5% Performs quality checks
* 10% Identifies resource needs and develops clinical research documents, such as job aids, tools, processes, procedures, and training. Contributes to the development of protocols
* 5% May assist with training of staff
* 5% Processes human subject and mileage payments
Institutional Statement on Diversity:
Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals.
The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world.
For more information on diversity and inclusion on campus, please visit: Diversity and Inclusion
Education:
Preferred
Bachelor's Degree
Area of study related to healthcare, biological sciences or nursing preferred
Qualifications:
* Two or more years of experience in human subjects research strongly preferred
* Experience coordinating randomized, placebo controlled clinical trials preferred
* Experience administering cognitive testing with older adults preferred
* Experience working with individuals from diverse racial, ethnic, and underserved communities preferred
* Phlebotomy skills or willingness to be trained in phlebotomy is preferred
* Experience with wet lab processing of biospecimens preferred
Individuals with relevant experience working in a non-research clinical health care role that required patient interaction will also be considered.
This position requires the ability to work in a hospital setting. Candidates must also have ability and willingness to work respectfully with an older and diverse population at the University of Wisconsin Hospital and William S. Middleton Memorial Veterans Hospital.
Strong analytical and interpersonal skills required. Ability to communicate effectively and diplomatically in written and verbal forms with research sponsors, faculty, researchers, participants and staff at all levels required. Excellent problem solving, organizational and computer skills required. The ability to manage many high level tasks at the same time and work independently with minimal supervision is required. A successful candidate will be adaptable to accommodate the needs of the position. A high level of professionalism is required. Knowledge of University and VA administrative policies and procedures as well as federal human subjects protection regulations highly desirable.
License/Certification:
Required
Drivers License - Valid and Meets UW Risk Management Standards
Travel is required. Must provide a valid driver's license. Employees may use their own transportation or receive approval for University Car Fleet usage. Employment is conditional pending the results of a Pre-hire Driver Authorization Check. See ********************************************************************************************************************************* (click on "Become an authorized driver;" then click on "Required criteria").
Work Type:
Full or Part Time: 50% - 100%
It is anticipated this position requires work be performed in-person, onsite, at a designated campus work location.
Appointment Type, Duration:
Ongoing/Renewable
Salary:
Minimum $47,000 ANNUAL (12 months)
Depending on Qualifications
The starting salary for the position is $47,000 but is negotiable based on experience and qualifications. Employees in this position can expect to receive benefits such as generous vacation, holidays, and sick leave; competitive insurances and savings accounts; retirement benefits. Benefits information can be found at (*******************************
Additional Information:
University sponsorship is not available for this position, including transfers of sponsorship. The selected applicant will be responsible for ensuring their continuous eligibility to work in the United States (i.e. a citizen or national of the United States, a lawful permanent resident, a foreign national authorized to work in the United States without the need of an employer sponsorship) on or before the effective date of appointment. This position is an ongoing position that will require continuous work eligibility. If you are selected for this position you must provide proof of work authorization and eligibility to work.
This position has been identified as a position of trust with access to vulnerable populations. The selected candidate will be required to pass an initial caregiver check to be eligible for employment under the Wisconsin Caregiver Law and every four years.
Primary work location will be on-site at the University of Wisconsin-Madison Hospital and Madison VA Hospital. Minimum travel is required for recruitment efforts. See License/Certification section for more details.
How to Apply:
To apply for this position, please click on the "Apply Now" button. You will be asked to upload a current resume/CV and a cover letter briefly describing your qualifications and experience.
Contact:
Kate Cronin
****************
************
Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.
Official Title:
Clin Res Coord II(RE016)
Department(s):
A53-MEDICAL SCHOOL/MEDICINE/GER-AD DEV
Employment Class:
Academic Staff-Renewable
Job Number:
311630-AS
The University of Wisconsin-Madison is an Equal Opportunity and Affirmative Action Employer.
Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. We promote excellence through diversity and encourage all qualified individuals to apply. For more information regarding applicant and employee rights and to view federal and state required postings, click here
If you need to request an accommodation because of a disability, you can find information about how to make a request at the following website: ******************************************************************************************
Employment may require a criminal background check. It may also require you and your references to answer questions regarding sexual violence and sexual harassment.
The University of Wisconsin System will not reveal the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7).
The Annual Security and Fire Safety Report contains current campus safety and disciplinary policies, crime statistics for the previous 3 calendar years, and on-campus student housing fire safety policies and fire statistics for the previous 3 calendar years. UW-Madison will provide a paper copy upon request; please contact the University of Wisconsin Police Department.
Travel Per Diem Mobile Research Nurse
Clinical Research Coordinator Job In Madison, WI
Science 37's Nursing Solutions Group brings together expert nurses who share a passion for organizing, planning and implementing mobile clinical nurse services to participants in clinical trials. Science 37's extraordinary work environment allows continuous collaboration between clinicians, clinical researchers, patient recruitment specialists, data managers and technology developers. The Nursing Solutions Group is involved throughout the trial life cycle, from protocol development and feasibility analysis to clinical trial implementation and closeout.
The Per Diem Mobile Research Nurse is a Registered Nurse who will work per diem and has experience across multiple therapeutic areas with the ability to work independently and integrate well with the Nursing Solutions Group. With interest/expertise in Science 37's decentralized model of care delivery, the Mobile Research Nurse will perform delivery of care to participants as well as collaborate with brick and mortar sites, if indicated, for shared clinical trial implementation. The Mobile Research Nurse ensures the professional delivery of patient care in compliance with all federal and state regulations, Good Clinical Practice, and Standard Operating Procedures.
* This is a travel role that requires on-site visits to participants homes.
Duties for this position include but are not limited to:
* Participate and provide research nurse services to qualified study participants at home
* Apply clinical research and nursing practices to develop solutions to complex problems
* Collaborate with Lead and Per Diem Mobile Research Nurses on solutioning, education, and resource support
* Participate in activities that will further the operational development of Science 37 nursing service delivery
* Develop relationships with study team members and serve as the subject matter expert (SME) on all nursing processes
* Other duties as assigned as the needs of Science 37 evolve and change
This position has the following qualifications:
* BSN degree preferred
* Full Covid Vaccination strongly preferred. Science 37 follows CDC guidelines for vaccination recommendations and such guidelines are subject to change.
* Active RN licensure in home state as well as eligibility for Compact Licensure required
* Minimum 2+ years clinical/research experience preferred
* Basic Life Support (BLS) Certification
* Maintain a positive reflection of the company by representation in participant's homes or in clinic settings
* Travel and availability qualifications are as follows:
* 1-2 days minimum a week dedicated to support Science 37's study visits
* Weekday/night availability required
* Must be willing to travel to a participants homes
* Active Driver's License
Science 37 is looking for people with the following skills and competencies:
* BSN degree preferred
* Active RN licensure in home state as well as eligibility for Compact Licensure required
* Minimum 2+ years clinical/research experience preferred
* Basic Life Support (BLS) Certification
* Active Driver's License
* Weekday/night availability required
* Maintain a positive reflection of the company by representation in participant's homes or in clinic settings
* Up to 100% travel, as needed, for study participant visits, project team meetings, and other professional meetings/conferences as needed
* Ability to obtain nursing license in multiple states based on study needs
* Physical ability to perform nursing tasks and lift equipment up to 15 kg in weight
* Access to a reliable vehicle to perform study participant visits and transport equipment
* Ability to drive to local and/or remote locations to perform study participant visits
* Ability to use technology effectively and appropriately for study participant assessments and documentation including but not limited to study participant care equipment, laptop computers, communication devices and tablets
* Ability to communicate in English (both verbal and written)
There is minimal supervision for this position, with individuals reporting to the Manager, Nursing Solutions Group.
Compensation varies based on location and work being performed. The starting pay range for a candidate selected for this position is generally within the range of $50-55 per hour. Employees may be eligible for additional discretionary bonuses and commissions. The successful candidate's actual pay will also be based on qualifications and experience, so the actual starting pay may be above or below this range.
Science 37 is an equal opportunity employer.
We are committed to creating a diverse environment and is an equal opportunity employer. All qualified applicants receive consideration for employment without regard to age, race, ethnicity (including but not limited to hair texture and protected hairstyles), ancestry, color, sex, national origin, sexual orientation, gender, gender identity, gender expression, transgender status, religious creed, physical or mental disability (including actual or perceived disability), medical condition (including HIV/AIDS), pregnancy, perceived pregnancy and pregnancy related conditions, genetic information, marital status, political affiliation or activities, status as a victim of domestic violence, assault, or stalking, veteran status or participation in the uniformed military services of the United States, including the National Guard, or any other basis prohibited by applicable law.
Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed.
Submit your resume to apply!
System Oncology Pharmacy Clinical Coordinator
Clinical Research Coordinator Job 33 miles from Madison
The primary job responsibility is to coordinate the delivery of optimal, safe and cost-effective oncology medication manage services across all dimensions of care system wide. In this role, the System Oncology Pharmacy Clinical Coordinator will provide advanced oncology operational and clinical pharmacy services through collaboration and teamwork. Provides pharmaceutical care in the specialty practice areas to patient ages pediatric through geriatric focusing on the hematology and oncology patient population. Maintains practice by ongoing professional literature review, continuing education and self-evaluation.
Responsibilities
ESSENTIAL DUTIES AND RESPONSIBILITIES
Assists with oncology services operational performance
* Recognizes and addresses operational and clinical opportunities for improvement.
* Leads in the development and implementation of new oncology service practices, workflows, guidelines, and policies in partnership with pharmacy department leadership
* Develops guiding principles, policies /procedures and tools that promote consistence across the system.
* Partners with oncology medical staff in developing evidence-based protocols and dosing guidelines in optimizing drug therapy in a cost-effective manner.
* Serve as a resource on investigational drug services and research teams including the provision of education, management of adverse drug events, collects and evaluate data, and participate on institutional review boards.
* Assists in the development and on-going maintenance of electronic health record orders sets, assists in optimizing computerized orders entry
Provides day-to day departmental leadership through mentorship and continuing education of clinical pharmacists
* May coordinate the intern and student programs
* Leads workgroups and team to meet objective, timelines, and budget of project and initiatives
* Develops and implements new and ongoing clinical training and competency evaluation
Operational and/or clinical education and initiatives
* Coordinate staff education, training and competency assessment
* Works collaboratively with leadership team to identify gaps in partner education and assist with performance improvement to close gaps
* Offers resources, training and assistance to ensure regulatory compliance including USP 800.
* May lead or coordinate site or system initiatives
Monitors financial outcomes
* Along with members of the patient care team assists in drug cost containment and reimbursement efforts across the system
* Partner with department leadership and others in minimizing drug waste, managing drug shortages, and optimizing 340B drug saving.
* Ensures projects are completed within the approved scope, timeline and budget
* Develop performance metrics based on quality of care, cost management and patient outcomes including but not limited to metrics such as decreasing drug cost per hospital admission/oncology clinic encounter, reducing adverse events or re-admissions, and managing high cost drug therapies
* Conduct Medication Use Evaluation (MUE) studies with an overarching goal of optimizing patient outcomes via ongoing evaluation and improvement of medication utilization. MUE studies will focus on high cost and/or high volume antineoplastic and other non-oncologic biologic agents including biosimilars.
* Coordinate the request, review, and approval of newly FDA approved oncology and other high cost biological agents for formulary consideration. That includes medication intended for administration in the acute care hospital setting or in outlying ambulatory clinic settings.
May prepare and dispense medications
* Requires passing annual sterile product compounding competency
* Completes chemotherapy compounding competency
* Prepares or certifies sterile products including chemotherapy preparations prepared by technicians.
CULTURE OF EXCELLENCE BEHAVIOR EXPECTATIONS
To perform the job successfully, an individual should demonstrate the following behavior expectations:
Quality - Follows policies and procedures; adapts to and manages changes in the environment; Demonstrates accuracy and thoroughness giving attention to details; Looks for ways to improve and promote quality; Applies feedback to improve performance; Manages time and prioritizes effectively to achieve organizational goals.
Service - Responds promptly to requests for service and assistance; Follows the Mercyhealth Critical Moments of service; Meets commitments; Abides by MH confidentiality and security agreement; Shows respect and sensitivity for cultural differences; and effectively communicates information to partners; Thinks system wide regarding processes and functions.
Partnering - Shows commitment to the Mission of Mercyhealth and Culture of Excellence through all words and actions; Exhibits objectivity and openness to other's views; Demonstrates a high level of participation and engagement in day-to-day work; Gives and welcomes feedback; Generates suggestions for improving work: Embraces teamwork, supports and encourages positive change while giving value to individuals.
Cost - Conserves organization resources; Understands fiscal responsibility; Works within approved budget; Develops and implements cost saving measures; contributes to profits and revenue.
EDUCATION AND EXPERIENCE
Graduate of an accredited pharmacy school of pharmacy
Completion of a PGY2 oncology specialty pharmacy residency program or 3 years of clinical oncology pharmacy experience in a progressive oncology clinical practice setting is required
CERTIFICATION/LICENSURE
Registered pharmacist in the state of Wisconsin and Illinois
Board of Pharmacy Specialty in Oncology and/or Sterile Compounding preferred.
ADDITIONAL REQUIREMENTS
Passing the Driver's License Check and/or Credit Check (for those positions requiring).
Passing the WI Caregiver Background Check and/or IL Health Care Workers Background Check.
Must be able to follow written/oral instructions.
OTHER SKILLS AND ABILITIES
Computer experience
Strong accuracy skills
WORK ENVIRONMENT
Occupational Exposure: Category C - No partners in the specified job classification have occupational exposure.
AGE OF PATIENTS SERVED
Non-Specific Task (N/A)
INFORMATION ACCESS
Partner may access patient care information, financial data, human resource data and strategic and planning data needed to perform their job duties as directed by the director.
WORK CONTACT GROUP
Partners, physicians, patients/family, visitors, and vendors
SPECIAL PHYSICAL DEMANDS
The Special Physical Demands are considered Essential Job Functions of the position with or without reasonable accommodations.
While performing the duties of this Job, the employee is regularly required to stand and talk or hear. The employee is frequently required to walk; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision and ability to adjust focus.
LEVEL OF SUPERVISION
Works independently under the supervision of the System Director of Pharmacy.
SUPERVISES
The job has no supervisory responsibilities.
Benefits
Mercyhealth offers a generous total rewards package to eligible employees including, but not limited to:
* Comprehensive Benefits Package: Mercyhealth offers a retirement plan with competitive matching contribution, comprehensive medical, dental, and vision insurance options, life and disability coverage, access to flexible spending plans, and a variety of other discounted voluntary benefit options.
* Competitive Compensation: Mercyhealth offers market competitive rates of pay and participates in various shift differential and special pay incentive programs.
* Paid Time Off: Mercyhealth offers a generous paid time off plan, which increases with milestone anniversaries, to allow employees the opportunity for a great work-life balance.
* Career Advancement: Mercyhealth offers a number of educational assistance programs and career ladders to support employees in their educational journey and advancement within Mercyhealth.
* Employee Wellbeing: Mercyhealth has a focus on wellbeing for employees across the organization and offers a number of tools and resources, such as an employer-sponsored health risk assessment and a Wellbeing mobile application, to assist employees on their wellbeing journey.
* Additional Benefits: Mercyhealth employees have access to our internal and external employee assistance programs, employee-only discount packages, paid parental and caregiver leaves, on-demand pay, special payment programs for patient services, and financial education to help with retirement planning.
Program Coordinator, State Democracy Research Initiative
Clinical Research Coordinator Job In Madison, WI
* Serves as the Initiative's administrative point person, handles all matters related to logistics, planning, scheduling, and record-keeping; * Monitors and analyzes current events and briefs colleagues on ongoing developments; * Manages the Initiative's communications, including its newsletter, social media, and website;
* Interfaces with student researchers to manage onboarding;
* Assists staff with the creation of designs for social media content, research data charts, and other research and informational needs;
* Plans and serves as the main point of contact for events, conferences, and other convenings;
* Tracks cases and news stories relevant to the Initiative's work;
* Other duties as assigned.
Responsibilities:
Administrative Assistant II (AD002)
Administrative Assistant III (AD003)
Institutional Statement on Diversity:
Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals.
The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world.
For more information on diversity and inclusion on campus, please visit: Diversity and Inclusion
Education:
Preferred
Bachelor's Degree
Preferred but not required.
Qualifications:
* Experience with administration or management in a professional setting;
* Ability to draft clear and effective public-facing communications through newsletters, email, and social media;
* Outstanding organizational skills and the ability to juggle multiple tasks while meticulously meeting deadlines;
* Experience organizing large numbers of documents;
* Ability and experience with typical software and programs used for administrative operations, including Microsoft Outlook, Zoom, Excel, Twitter (or similar social medial platforms), and Canva;
* Comfort working in a dynamic environment;
* Excellent diplomatic skills, experience working both independently and as part of a team;
* Curiosity about the law and willingness to contribute to research projects.
Work Schedule:
Regular office hours are 7:45am - 4:30pm with a 45 minute lunch break, but this schedule may vary slightly and will be agreed upon at hire.
Work Type:
Full Time: 100%
It is anticipated this position requires work be performed in-person, onsite, at a designated campus work location. Some work may be able to be performed off-site with agreement of the supervisor after a successful training and evaluation period.
Appointment Type, Duration:
Ongoing/Renewable
Salary:
Minimum $19.23 HOURLY
Depending on Qualifications
Starting salary and title (Admin Assist II or III) will be based on successful candidate's prior experience and expertise.
Additional Information:
The State Democracy Research Initiative at the University of Wisconsin Law School, ************************************* seeks a Program Coordinator to join our team. In this role, your organization and management skills will support our multi-faceted, nonpartisan efforts to foster research and dialogue on pressing questions of public law and democracy in states across the nation.
The Initiative's work is rooted in the idea that to preserve democracy, we must first understand it. Currently, scholarly and popular discourse on U.S. democracy focuses disproportionately on federal laws and institutions. States often get short shrift, even though they are central to our democratic system. Accordingly, the Initiative aims to foster knowledge of and engagement with state-level institutions throughout the country.
The Program Coordinator will have a varied portfolio of communications, organizational, and programmatic tasks. A typical day might include drafting the Initiative's newsletter and social media; coordinating the logistics for conferences or panels; handling recordkeeping and budgeting tasks; creating graphics for a research report; tracking relevant new stories and state cases; and working on research projects to support the Initiative's mission.
The ideal candidate will be exceptionally organized and reliable, excited about the Initiative's mission, and a team player with enthusiasm for working with peers and students alike. We encourage and welcome applications from candidates with varied backgrounds, experiences, and perspectives.
How to Apply:
Applicants must apply through the Jobs at UW website (****************** by submitting a cover letter and resume to job #314000 by the consideration date.
Contact:
Justin Boehm
*********************
************
Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.
Official Title:
Administrative Assistant II(AD002) or Administrative Assistant III(AD003)
Department(s):
A45-LAW SCHOOL/LAW SCHOOL/LAW SCHOOL
Employment Class:
University Staff-Ongoing
Job Number:
314000-CP
The University of Wisconsin-Madison is an Equal Opportunity and Affirmative Action Employer.
Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. We promote excellence through diversity and encourage all qualified individuals to apply. For more information regarding applicant and employee rights and to view federal and state required postings, click here
If you need to request an accommodation because of a disability, you can find information about how to make a request at the following website: ******************************************************************************************
Employment may require a criminal background check. It may also require you and your references to answer questions regarding sexual violence and sexual harassment.
The University of Wisconsin System will not reveal the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7).
The Annual Security and Fire Safety Report contains current campus safety and disciplinary policies, crime statistics for the previous 3 calendar years, and on-campus student housing fire safety policies and fire statistics for the previous 3 calendar years. UW-Madison will provide a paper copy upon request; please contact the University of Wisconsin Police Department.
Research Cyberinfrastructure Cloud Consultant
Clinical Research Coordinator Job In Madison, WI
The Research Cyberinfrastructure group at the University of Wisconsin-Madison, Division of Information Technology is hiring a Research Cyberinfrastructure Cloud Consultant. The Research Cyberinfrastructure Cloud Consultant will provide end user support and training for researchers using public cloud computing resources for research workflows. You will provide support and guidance to researchers to enable them to leverage a variety of university hosted and public cloud computing resources for machine learning and data science research. In this role, you will be responsible for responding to user requests and issues related to these resources. You will become expert at matching the needs of researchers to the evolving suite of services and resources for AI and data science and to best practices for using them. You will develop and deliver workshops, training, and documentation for researchers, in partnership with groups in central and distributed IT, research computing centers, and the Data Science Hub. Your work will help researchers use key elements of research computing infrastructure, in support of the University's RISE (Research Innovation and Scholarly Excellence) initiative.
University of Wisconsin-Madison is a leading research university, known for interdisciplinary research that creates new knowledge and innovations that benefit society and improve lives around the world.
The Research Cyberinfrastructure unit, within the Division of Information Technology, team is a group of IT professionals that provides services and support to researchers for their data, computing, data science, and AI-based work. Our mission is to provide a robust, secure, and evolving infrastructure that enables the work of researchers in all disciplines and aligns with UW-Madison's research mission and strategic priorities. To do this, we partner extensively with groups in central and distributed IT, research computing centers, the Data Science Institute, and the Libraries. We focus on providing high quality, reliable services while continuously exploring and learning new technologies that will become transformative for research.
The Division of Information Technology (DoIT) is an exciting and dynamic work environment grounded in organizational principles that include family and personal life/work balance; an inclusive, respectful, and supportive work environment; professional development opportunities; innovation; and alignment with the campus's teaching, learning, and research missions.
Responsibilities:
Applies computational, computer science, data science, and cyber infrastructure (CI) research and development principles to provide advanced and varied consultation on research and technology integration and development. Provides non-routine maintenance, planning, and advanced troubleshooting to ensure CI resources meet research needs. Provides guidance and training to other staff and serves as subject matter expert for internal stakeholders.
* 20% Serves as a CI domain expert, provides direct support of users, other staff providing support of users, and advanced computing systems
* 30% Provides expertise and experience in CI to lead troubleshooting, analysis, operation, and support of advanced computing systems and for research
* 30% Develops unique and custom Cyber Infrastructure solutions for research needs
* 20% Writes and updates documentation and tutorials supporting CI activities for research. May provide brief courses for internal researchers and external collaborators
Institutional Statement on Diversity:
Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals.
The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world.
For more information on diversity and inclusion on campus, please visit: Diversity and Inclusion
Education:
Preferred
Bachelor's Degree
Qualifications:
Required
* Professional experience supporting researchers and/or other clients as a member of an IT, Library, or computing service organization or research lab, group, or center
* Professional experience developing technical documentation, tutorials, training, or other support materials for end users
* Professional experience designing, implementing, and maintaining resources and solutions in Amazon Web Services (AWS), Microsoft Azure, or Google Cloud Platform (GCP)
* Demonstrated experience using coding skills in a professional work environment in one or more of the following: Python, R, or comparable language(s)
Preferred
* Professional Experience deploying machine learning models on public cloud platforms
* Professional experience developing automated processes for data analysis, extraction, or formatting using REST APIs, scripting languages, or other tools
* Familiarity with current storage, computation, and data-intensive workflows in one or more research disciplines
* Awareness of security protocols and regulatory compliance (i.e., HIPAA, FedRAMP, Controlled Unclassified Information) areas that impact research
* Basic skills and experience with at least one of the following platforms: Vscode, RStudio, git, Jupyter Labs/Notebook, GitHub/GitLab
Work Type:
Full Time: 100%
Hybrid: The candidate selected for this position may perform a combination of on-site and remote work subject to an approved remote work agreement (RWA) agreement, which is reviewed and approved annually. Remote work requires successful candidates to possess their own high-speed internet and phone to perform the work on a university provided computer. Per University policy, transportation between home and assigned work location is not payable/reimbursable and will be at the expense of the employee.
Appointment Type, Duration:
Ongoing/Renewable
Salary:
Minimum $85,000 ANNUAL (12 months)
Depending on Qualifications
Starting salary will be based on experience and qualifications. Well qualified applicants can anticipate to earn between $85,000 - $97,000, with final salary based on experience and qualifications.
Employees in this position can expect to receive benefits such as generous vacation, holidays, and paid time off; competitive insurances and savings accounts; retirement benefits.
Additional Information:
Please note that successful applicants must be authorized to work in the United States without need of employer sponsorship, on or before the effective date of appointment. University sponsorship is not available for this position.
This position is part of the Wisconsin Research, Innovation and Scholarly Excellence (RISE) Initiative. Through accelerated and strategic faculty hiring, research infrastructure enhancement, interdisciplinary collaboration, and increased student and educational opportunities, RISE addresses complex societal challenges of importance to the state, nation and world. Building on UW-Madison's strengths, RISE expands the University's successful track record of connecting with communities and industry on collaborative solutions.
Over the next three academic years, UW-Madison will substantially increase current research computing personnel and hardware infrastructure. Candidates hired through RISE will join a community of scholars working across disciplines, schools and colleges on research, teaching and outreach endeavors. The RISE community, and extended campus community, will engage regularly in venues such as seminar series and colloquia to share ongoing projects and identify opportunities to work together. The University will support the community, facilitating access to research infrastructure, and funding to support broad and rich collaboration.
Further information regarding RISE can be found at: **********************
How to Apply:
Click on the "Apply Online" button to start the application process.
You will be prompted to upload the following documents:
Resume
Letter of Qualifications
Applicants should attach a letter of qualifications and resume detailing their training and experience relating to the required and preferred qualifications referenced above. The application reviewers will be relying on written application materials to determine which qualified applicants will advance in the recruitment process.
Contact:
Charissa Weber
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Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.
Official Title:
Research CI Spec II(RE074)
Department(s):
A06-INFORMATION TECHNOLOGY/CTO OFFICE
Employment Class:
Academic Staff-Renewable
Job Number:
313601-AS
The University of Wisconsin-Madison is an Equal Opportunity and Affirmative Action Employer.
Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. We promote excellence through diversity and encourage all qualified individuals to apply. For more information regarding applicant and employee rights and to view federal and state required postings, click here
If you need to request an accommodation because of a disability, you can find information about how to make a request at the following website: ******************************************************************************************
Employment may require a criminal background check. It may also require you and your references to answer questions regarding sexual violence and sexual harassment.
The University of Wisconsin System will not reveal the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7).
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