Sr Clinical Research Specialist
Clinical research coordinator job in Minneapolis, MN
Collabera Inc (Staffing Firm). We are based out of Morristown, NJ and we have been providing contingent labor to our clients for last 25 years. In 2015 we placed more than 6,000 contractors across select 100+ clients that we service. End client for this project is a large legal organization
with operations in more than 100 countries and has more than 50,000 employees around the world. For eight consecutive years, Fortune has named this company as World's ‘Most Admired Companies to work for'.
Job Description
Position Description:
The Sr. Clinical Research Specialist (Sr. CRS) will support the execution of clinical research activities related to the ongoing evaluation of product safety and effectiveness following market release. Under supervision, the Sr. CRS may assume project management responsibilities for assigned studies and will be responsible for the timely completion of deliverables consistent with applicable regulatory standards and internal Medtronic requirements.
Position Responsibilities:
• Prepare and revise study materials and/or training
• Conduct training of site and/or Medtronic staff
• Assist in site initiation activities (e.g. study start-up documentation preparation)
• Set-up and maintain accurate progress and study status tracking logs
• Assist in the preparation of reports, regulatory submissions, publications and presentations
• Assist in the preparation of budgets and project plans
• Identify and mitigate quality risk and/or issues associated with assigned studies/activities
• May arrange conference calls, staff meetings, and training events.
• Assist in the preparation and review of data
• Oversee follow-up and resolution of sites issues
• Oversee activities performed by extended team members including work direction (e.g. project coordinators, monitors, safety and data specialists, etc.) to ensure compliance with protocol, appropriate regulations and guidelines
• Able to refer to Standard Operating Procedures (SOPs) and study management processes for guidance on everyday tasks
• Contribute to process improvement initiatives and participate in training to enhance knowledge
Qualifications
Basic Qualifications:
• Bachelors degree
• 4+ years' experience in clinical research (Masters degree will substitute for 1 year experience)
Desired/Preferred Qualifications:
• Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for conducting clinical studies
• Proficient knowledge of medical terminology
Additional Information
If you are interested and want to apply, please contact:
Ebrahim Sayarwala
ebrahim.sayarwala(at
)collabera.com
************
Clinical Research Associate - NAMSA Future Openings USA
Clinical research coordinator job in Minneapolis, MN
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
* Act with integrity in everything we do.
* Provide best-in-class customer experiences.
* Develop superior talent and deliver expertise.
* Respond with agility and provide timely results.
* Embrace collaboration, diverse perspectives and ideas.
Job Description:
* Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed.
* Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines.
* May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits.
* Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed.
* Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns.
* Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc.
* Performs study-related training.
* Manages the development and maintenance of study documents, processes and systems as assigned.
* Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals.
* Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance.
* Attends internal and external meetings as required.
* Provides all job-related progress reports and visit documentation as required.
* May support safety activities such as narrative writing, managing the CEC/DSMB, etc.
* OUS: Prepares and coordinates submissions to regulatory authorities.
* May perform other activities as assigned.
Qualifications & Technical Competencies:
* Fluency in English and local language, if different, required.
* Higher education degree or equivalent education, training, and experience.
* Preferred 2 years clinical trial experience.
* Preferred monitoring experience.
* Able to work independently once trained.
* Good verbal and written communication skills.
* Strong organizational skills.
* Basic computer proficiency.
* Understanding of clinical research processes and regulations.
* Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required
Working Conditions:
* Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates.
* The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; 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, depth perception, and ability to adjust focus.
* Extensive use of a computer keyboard.
Pay Range Minimum:
$54,400.00
Pay Range Target:
$80,100.00
Pay Frequency:
Annual
Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.
NAMSA is an equal employment opportunity company.
NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.
Fair Chance Employment Statement:
At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history.
Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position:
* May operate equipment
* Records data timely and accurately
* May analyze and interpret data
* Conducts studies on medical devices that have an impact on human life
A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.
Auto-ApplyClinical Research Coordinator /Psychologist
Clinical research coordinator job in Bloomington, MN
Build Something Bigger - And Change Lives, Including Your Own. In 1935, Louise Whitbeck Fraser opened a school in her home for people with disabilities - defying social expectations and choosing compassion over convention. She believed everyone deserves the chance to reach their potential and thrive. Today, that same bold spirit is alive in every Fraser service. We're still building something bigger - a more inclusive, connected world where everyone belongs. At Fraser, you'll find more than a job. You'll find purpose. You'll find growth. And you'll find a place where your work changes lives - including your own.
Fraser is seeking a Clinical Research Coordinator to serve as a scientific resource and supports Fraser research projects by coordinating activities, analyzing data, and communicating research findings to internal and external stakeholders regarding clinical outcomes in Specialty Healthcare. In addition,provide psychological assessment, intervention, and consultation for clients and families.
Responsibilities:
Scientific Resource:
Manage and review study protocols/requests from internal and external stakeholders to assess relevance and resources available for such projects.
Provide research reviews for staff requests that support the clinical operations of Fraser.
Research Coordinator:
Serve as Research consultant for staff examining clinical research.
Under direction of Medical Director/Chief Clinical Officer identify primary projects that focus resources for collecting data, analyzing and communicating outcomes.
Perform data collection, analysis, and reporting.
Continuously audit database and identify issues of risk and process improvements to ensure accuracy and efficiency.
Work in collaboration with Database Administrator to ensure successful integration of data collection and evaluation metrics into our electronic health record and practices.
Data Anlayst:
Perform data collection, analysis, and reporting.
Continuously audit database and identify issues of risk and process improvements to ensure accuracy and efficiency.
Perform data collection interviews and data entry.
Work in collaboration with Database Administrator to ensure successful integration of data collection and evaluation metrics into our electronic health record and practices.
Psychologist:
Participate in psychological testing for clients with social, behavioral, emotional, and developmental concerns.
May deliver individual and family psychotherapy, including diagnostic assessments and treatment planning.
May provide group therapy, for siblings, adults, parents, and children.
Provide consultation and coordination of services with others involved with the client, such as the school, county, courts, biological family, foster parents.
Schedule and provide clinical services and documentation in such a way as to meet or exceed budgeted client service hour targets.
Requirements:
MA, MS, Psy.D., Ph.D. in Psychology required, or other graduate degree with research experience that demonstrates understanding and skill for research activities.
Current active Psychology licensure from the State of Minnesota.
Training and experience in clinical research required.
Valid Minnesota Driver's License with acceptable record.
Commitment to promoting diversity, multiculturalism, and inclusion with a focus on culturally responsive practice, internal self-awareness, and reflection.
Schedule, Location and Pay:
Monday- Friday standard business hours
.5 FTE Research Coordinator
.5 FTE Psychologist
Fraser Bloomington, MN
Hybrid
$105,000 - $115,000 annually dependent upon qualifications
Fraser Offers:
Collaborative and relationship-oriented culture
Scheduled performance feedback
Career growth opportunities
Opportunities for community involvement in Fraser organized events.
Collaborative and relationship-oriented culture
Fraser Offers Benefits for Full-time Employees (30+ hours per week)
Medical, dental and vision insurance
Health Savings Account (HSA) and Flexible Spending Account (FSA)
Employee Assistance Plan (EAP)
Life, AD&D and Voluntary Life Insurance
Long-Term Disability, Voluntary Short-Term Disability, Accident Insurance, Critical Illness Insurance and Hospital Indemnity Insurance
Pet Insurance
403(b) Retirement Plan with Company Match
Work-Life Balance; 5 weeks of paid time off annually (18 days PTO + 9 Paid Holidays)
Employee Referral Bonuses
Why Join Fraser?
Meaningful Impact
Help individuals and families lead more connected, independent, and fulfilling lives. Your impact here is real - and lasting.
Competitive Pay & Benefits
Fraser offers fair pay and comprehensive benefits that support your health, well-being, and future goals.
Flexibility & Work-Life Balance
With flexible schedules, generous paid time off, and wellness programs, Fraser helps you care for others without sacrificing yourself.
Grow Your Career With Us
We invest in your development with training, licensure support, leadership pathways, and real opportunities to advance.
Culture That Lives Its Values
Inclusion isn't just a buzzword - it's how we operate. You'll be seen, heard, and supported to bring your full self to work.
Thrive with Stability and Purpose
With nearly 90 years of trusted service and continued growth, Fraser is a nonprofit where you can build a lasting, mission-driven career.
Fraser is Minnesota's leader in autism, mental health, and disability services - and one of the few Certified Community Behavioral Health Clinics (CCBHCs) in the state. As a nonprofit organization, we provide integrated community behavioral healthcare that improves quality, accessibility, and coordination of care. We lead with compassion, innovate with purpose, and fight for inclusion - every single day. Ready to Build Something Bigger? Join Fraser. Grow with us. Make a difference. Because when you thrive, so does the world around you.
Diversity, Inclusion, and Belonging: Fraser values a diverse staff to ensure the best outcomes for our diverse client base. We are committed to anti-racism at Fraser. Our anti-racism committee assesses, develops, and implements numerous initiatives ranging from recruiting and retaining diverse staff to staff training and more.
Fraser is an Affirmative Action and Equal Opportunity Employer.
This position will be posted at
******************************
until filled. You must apply online here to be formally considered.
If you are having trouble applying or have questions, please contact Fraser HR at ****************** or ************. If you have successfully submitted your application, you will get a confirmation email. If you do not receive the confirmation email, please check your junk/spam folders; then contact us as we may not have received your application. Thank you for considering Fraser!
Easy ApplyUX Research Coordinator
Clinical research coordinator job in Milwaukee, WI
About the Job: The Research Coordinator's role is to help the research practice operate more efficiently. They do this by handling the logistics to make research run smoothly so that researchers can focus on what they do best - conduct research. Research Coordinator duties may include project and client management, creating and managing materials for research, participant recruitment and session scheduling, incentive management, tool and data management, etc.
What You'll Do:
Coordinate research participant recruitment
o Identify and recruit research participants per researcher specifications
o Coordinate schedules of research participants, researchers, and stakeholders
o Manage incentives
o Manage lists of past and future research participants
Manage software systems used for data collection and analysis
Coordinate with Design Program Managers, Design Leads, and other stakeholders
Work as part of the larger Design Operations team and may be called upon to do operational work for the broader design organization.
If capacity allows, manage projects across the research organization. Including
o Prepare study materials and data collection tools for research sessions
o Schedule planning, research, and report-out sessions for researchers
o Prepare data for analysis
o Create and manage data repositories and handle records retention
Skills You Have:
Bachelor's degree, or equivalent
Experience providing operational support to fast-paced research teams.
Experience with research participant recruitment
Demonstrated skills in increasing team efficiency.
Strong communication and organizational skills with attention to the right details to ensure operations run smoothly
An ability to anticipate and proactively solve logistical issues so your team knows they'll never miss a beat when you're coordinating their work
Additional Qualifications We'd Love:
2 years' experience collaborating with live research teams.
Experience working in a highly regulated environment like healthcare or financial services.
Professional association with the Research Ops community.
#LI-Hybrid
Compensation Range:
Pay Range - Start:
$60,340.00
Pay Range - End:
$112,060.00
Geographic Specific Pay Structure:
Structure 110:
$66,360.00 USD - $123,240.00 USD
Structure 115:
$69,370.00 USD - $128,830.00 USD
We believe in fairness and transparency. It's why we share the salary range for most of our roles. However, final salaries are based on a number of factors, including the skills and experience of the candidate; the current market; location of the candidate; and other factors uncovered in the hiring process. The standard pay structure is listed but if you're living in California, New York City or other eligible location, geographic specific pay structures, compensation and benefits could be applicable, click here to learn more.
Grow your career with a best-in-class company that puts our clients' interests at the center of all we do. Get started now!
Northwestern Mutual is an equal opportunity employer who welcomes and encourages diversity in the workforce. We are committed to creating and maintaining an environment in which each employee can contribute creative ideas, seek challenges, assume leadership and continue to focus on meeting and exceeding business and personal objectives.
Auto-ApplyClinical Study and Biospecimen Coordinator
Clinical research coordinator job in Rochester, MN
Salary range: $52,000-$67,000 Full-time. Exempt, salaried. The Clinical Study and Biospecimen Coordinator (CSC) plays a key role in supporting the operational execution of Vyriad's Phase 1/2 clinical trials and will be responsible for managing biospecimens used for exploratory and translational research. This position is critical in coordinating supply of test kits and receipt of clinical samples, ensuring high-quality sample collection, processing, shipping, tracking, and documentation across a network of clinical sites and research laboratories. The candidate will maintain sample inventory, receive data reports and be responsible for data entry and analysis. The CSC will collaborate closely with Clinical Operations, Translational Science, external vendors, and clinical sites to maintain compliance, ensure protocol adherence, and facilitate timely generation of high-quality data.
Supervisory Responsibilities
None
Duties and Responsibilities
Clinical Study Coordination
* Assist in day-to-day oversight of multiple ongoing Phase 1/2 trials, supporting study start-up, conduct, and close-out activities
* Maintain and update study trackers, timelines, enrollment metrics, and essential documentation
* Support preparation, review, and approval of study materials (e.g., site training slides, study manuals, sample handling guides, visit worksheets)
* Coordinate and document study team meetings, vendor meetings, and cross-functional check-ins
* Monitor site performance metrics and assist with issue identification, follow-up, and escalation
* Work with CROs, central labs, and vendors to ensure deliverables are met according to the study plan
* Support data review activities such as data listings checks, lab reports reconciliation, and query management
Biospecimen & Exploratory Testing Management
* Serve as the primary operational contact for test kits, biospecimen collection, processing, and logistics across clinical sites
* Ensure all sample-related procedures follow protocol requirements, sample manuals, IATA regulations, and GCP guidelines
* Track and log daily/weekly sample collections, deviations, processing results, and shipments using internal LIMS system and eCRF
* Coordinate shipment logistics including temperature-controlled handling, courier pickup scheduling, and documentation
* Receives correlative research data reports and ensures data entry and analysis
* Work closely with patient management and operations teams at clinical sites to align sample workflows with central lab biomarker analysis needs
* Maintain complete, accurate sample chain-of-custody records and promptly address discrepancies
* Support biorepository activities such as inventory reviews, sample labeling audits, and sample reconciliations
* Assist in onboarding and training clinical sites on biospecimen handling procedures, including updates to sample manuals and shipping instructions
Additional duties as assigned.
Education and Experience
* Bachelor's degree in Life Sciences or related field; Masters degree a plus but not required
* 2+ years of experience in clinical research or clinical operations, ideally within a biotech or early-phase trial environment
* Prior hands-on experience with biomarker operations (eg. biospecimen handling, central lab coordination, translational research workflows, etc.) strongly preferred
* Familiarity with oncology Phase 1/2 study designs, PK/PD sampling and data evaluation desirable
Required skills and/or qualifications
* Working knowledge of GCP/ICH guidelines, clinical trial conduct, and regulatory documentation
* Strong understanding of specimen types (e.g., whole blood, serum, plasma, PBMCs, tumor tissue) and proper collection/processing requirements
* Highly organized with the ability to manage multiple tasks simultaneously across studies
* Strong communication and interpersonal skills for effective collaboration with internal central lab staff, clinical operations team members, vendors, and site staff
* Detail oriented with excellent documentation, tracking, and problem-solving abilities
* Ability to adapt quickly and work effectively in a fast-paced, dynamic environment.
* Strong problem-solving skills with the ability to navigate ambiguous situations and make sound decisions.
* Proficiency with EDC systems, LIMS/sample-tracking tools, and Microsoft Office tools
Physical Requirements
* Prolonged periods of sitting at a desk and working on a computer.
* Must be able to lift up to 15 pounds at times.
Benefits
* Group Healthcare Plan, including company paid dental and vision.
* Short- and long-term disability, life and AD&G insurance.
* Simple IRA with employer match
* Educational assistance program
* Holiday and PTO
Associate Clinical Research Coordinator - Comprehensive Cancer Center
Clinical research coordinator job in Rochester, MN
**Why Mayo Clinic** Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans (************************************** - to take care of you and your family, now and in the future. And with continuing education and advancement opportunities at every turn, you can build a long, successful career with Mayo Clinic.
**Benefits Highlights**
+ Medical: Multiple plan options.
+ Dental: Delta Dental or reimbursement account for flexible coverage.
+ Vision: Affordable plan with national network.
+ Pre-Tax Savings: HSA and FSAs for eligible expenses.
+ Retirement: Competitive retirement package to secure your future.
**Responsibilities**
**This is a hybrid position and will require the candidate to be within reasonable driving distance of the Rochester, MN campus.**
Coordinates non-therapeutic (i.e. minimal risk, survey, chart review) clinical research protocols with direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines. May assist in complex (i.e. interventional, therapeutic, greater than minimal risk) studies with direction but does not have overall responsibility for these studies. Screens, enrolls, and recruits research participants. Coordinates schedules and monitors research activities and subject participation. Recognizes adverse events, protocol deviations, and other unanticipated problems and reports appropriately. Collects, abstracts, and enters research data. Performs administrative and regulatory duties related to the study as assigned. Some travel may be required. ADDENDUM (if applicable) Protocol Development and Maintenance Activities Responsibilities may include, but are not limited to: ongoing management of the protocol document and process through editing, amendments, proofing, coordination of study logistics (i.e. data collection booklets, use of CRU, etc.), and verification of content to meet institutional and federal standards; Institutional Review Board (IRB) submission; and communication with study sites and/or federal agencies regarding study status changes. Participates in other protocol development activities and executes other assignments as warranted and assigned.
**During the selection process you may participate in an OnDemand (pre-recorded) interview that you can complete at your convenience. During the OnDemand interview, a question will appear on your screen, and you will have time to consider each question before responding. You will have the opportunity to re-record your answer to each question - Mayo Clinic will only see the final recording. The complete interview will be reviewed by a Mayo Clinic staff member and you will be notified of next steps.**
***Visa sponsorship is not available for this position. This position is not eligible for F-1 OPT STEM extension.**
**Qualifications**
+ HS Diploma with at least 3 years of experience OR
+ Associate's degree/college Diploma/Certificate Program with at least 1 year of experience OR
+ Associate's in Clinical Research from an accredited academic institution without experience OR
+ Bachelor's degree.
+ Experience should be in the clinical setting or related experience.
**Additional Qualifications**
+ Graduate or diploma from a study coordinator training program is preferred.
+ One year of clinical research experience is preferred.
+ Medical terminology course is preferred.
**Exemption Status**
Nonexempt
**Compensation Detail**
$24.07 - $34.95 / hour
**Benefits Eligible**
Yes
**Schedule**
Full Time
**Hours/Pay Period**
80
**Schedule Details**
Monday through Friday, no weekend no Holidays. Hours between 6am and 6pm.
**Weekend Schedule**
None
**International Assignment**
No
**Site Description**
Just as our reputation has spread beyond our Minnesota roots, so have our locations. Today, our employees are located at our three major campuses in Phoenix/Scottsdale, Arizona, Jacksonville, Florida, Rochester, Minnesota, and at Mayo Clinic Health System campuses throughout Midwestern communities, and at our international locations. Each Mayo Clinic location is a special place where our employees thrive in both their work and personal lives. Learn more about what each unique Mayo Clinic campus has to offer, and where your best fit is. (*****************************************
**Equal Opportunity**
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, protected veteran status or disability status. Learn more about the "EOE is the Law" (**************************** . Mayo Clinic participates in E-Verify (******************************************************************************************** and may provide the Social Security Administration and, if necessary, the Department of Homeland Security with information from each new employee's Form I-9 to confirm work authorization.
**Recruiter**
Chad Musolf
**Equal opportunity**
As an Affirmative Action and Equal Opportunity Employer Mayo Clinic is committed to creating an inclusive environment that values the diversity of its employees and does not discriminate against any employee or candidate. Women, minorities, veterans, people from the LGBTQ communities and people with disabilities are strongly encouraged to apply to join our teams. Reasonable accommodations to access job openings or to apply for a job are available.
Clinical Trial Coordinator
Clinical research coordinator job in Plymouth, MN
Our dynamic, clinical-stage, fast-paced medical device startup is developing novel technologies with the potential to significantly change population health. Every team member is a key contributor, directly impacting the company's progress towards commercialization. They offer a challenging yet rewarding environment where individuals can thrive and see the direct impact of their work. Due to an internal promotion, they are seeking a Clinical Trial Payments/Clinical Trial Coordinator.This role is a backfill to support an existing team member's growth into a Clinical Research Associate role. The specialist will be crucial in managing clinical trial payments and operating within their Clinical Trial Management System for new in-house projects. This position offers a significant growth opportunity for the right individual.
Your role with the company:
Clinical Trial Payments (approx. 50% of role):
Manage and oversee clinical trial payments, which will be a heavy focus for at least the next year.
Conduct administrative tasks and auditing of payments processed by their third-party vendor, Ledger Run.
Navigate complex and often inconsistent clinical trial contracts, ensuring accurate and timely payments.
Address various invoiceable items and ensure consistency across sites.
Requires a strong understanding of clinical trial nuances; general bookkeeping experience is insufficient.
CTMS Management (approx. 50% of role):
Operate and manage activities within the Clinical Trial Management System (CTMS), specifically Simple Trials.
Perform filing, binder creation, and other essential TMF/CTMS management duties for two new in-house projects (no CRO involvement for U.S. operations).
Experience with other CTMS systems is valuable and should allow for quick adaptation to Simple Trials.
General Clinical Trial Assistance:
Take meeting minutes.
Provide presentation assistance.
Contribute to other ad hoc tasks as needed within a small, dynamic team.
Desired Profile:
Proven experience in clinical trial payments is essential.
Familiarity and comfort operating within a Clinical Trial Management System (CTMS).
Ability to work effectively in a fast-paced environment.
Openness to feedback and a straightforward communication style.
Strong organizational skills and attention to detail.
Experience in a healthcare setting is a plus.
Ability to manage multiple tasks and priorities.
Clinical Research Coordinator - Germantown, WI - Part-Time
Clinical research coordinator job in Germantown, WI
SiteBridge Description: Founded in 2021, SiteBridge Research is a community-focused integrated research organization, building a national network of community practices to deliver world-class industry sponsored clinical research on time and on budget, accelerating time to market and product adoption in communities that are the most vulnerable and the hardest to reach. The SiteBridge network extends reach further into these communities to empower a broader set of patients with some of the highest unmet needs to take part in clinical research to improve health outcomes.
Job Description: Clinical Research Coordinator/Research Nurse - Contractor
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Clinical Principal Investigator (PI) on multiple ongoing research studies. While the Principal Investigator is ultimately responsible for the clinical trial, the CRC is responsible for the facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study. The CRC works collaboratively with the entire site team, sponsors, and clinical monitors to ensure ICH/GCP compliance, site productivity, and timely completion of studies. In addition, and most importantly, this role represents our mission and vision by focusing on the trusted physician/patient partnership from start to finish for every clinical trial conducted at the site and is key in transforming clinical research for every participant. The position will be responsible for specific clinical site activities to maintain the operational excellence required of clinical sites/staff involved in clinical studies and to assure compliance with protocol-specific procedures, data acquisition, and records management. This role will report to the Director, Clinical Site Development Operations and Study Management.
Location: The position is located in Germantown, WI and will be required to be on-site.
Job Type: This is an (1099) Independent Contractor position and is part-time to begin with potential to move into full-time based on study needs.
Responsibilities:
* Ensure clinical study compliance with local and federal laws and regulations according to ICH/GCP Guidelines
* Ensure study feasibility assessments for contracted sponsor-initiated studies
* Assist the Clinical/Site Ops Leads on the set-up/start-up of research site to prepare for start-up and conduct of clinical trials
* Lead oversight of pre-study, site initiation, and close-out visits with sponsor or CRO
* Consult with Site Leads, sponsor, and CRO to determine the best recruitment practices for site and trials
* Track study activities to ensure compliance with standard operating procedures (SOPs), protocols, and all related local, state, and national regulatory and institutional policies
* Arrange screening and recruitment of potential study participants by scheduling visits to establish Informed Consent and perform intake assessments according to protocols
* Create and maintain all essential documents and records related to the study
* Act as a point of reference for study participants by answering questions and keeping them informed on the study's progress
* Oversee and/or manage the inventory of equipment and supplies related to the study, including documentation, reporting of issues, and ordering clinical supplies as needed
* Communicate with laboratories and clinical investigators to ensure review and reporting of lab results and other clinical testing results
* Direct the request, collection, labeling, storage, or shipment of interventional products
* Ensure collection of specimens, questionnaire information, and input of data and patient information into electronic clinical systems
* Monitor the enrollment status of participants at the site for each specific clinical study
* Operate as primary contact for sponsors/CROs to schedule and coordinate site visits and answer queries
* Participate in meetings (Investigator Meetings, Site Trainings, etc.) and seminars to update knowledge of clinical research and related issues
* Prepare or participate in quality assurance audits and inspections performed by sponsors/CROs, regulatory authorities, or exclusively designated review groups
* Provide regular updates to Site Clinical Investigator(s) and Clinical/Site Ops Leads on study progress related to recruitment, compliance, and other study-related matters
Qualifications & Required Experience:
* Candidates with pediatric experience strongly encouraged to apply.
* Bachelor's degree in a relevant life science discipline is preferred; LPN/RN is preferred; certification as CCRC/CCRP is a plus; Education requirement exceptions can be made based on relevant clinical research experience
* Minimum 1 year of experience in clinical research. Number of years of previous experience working in a clinical research setting; number of years of clinical site/trials experience will determine position level
* Excellent working knowledge of FDA & ICH GCP regulations and guidelines is required
* Strong preference for experience with late-phase and observational clinical research
* Managing necessary clinical study and staff records related to clinical study activities including: case report forms, drug dispensation records, etc.
* Preparing advertising and other educational materials and conducting campaigns to recruit and enroll subjects
* Preparing trial-related document support such as protocol worksheets, adverse event reports, IRB documents, procedural manuals, and progress reports
* Experience identifying, reviewing, and reporting adverse events, protocol deviations, or other unanticipated problems appropriately to investigators and/or regulatory agencies
* Assessing risk factors in study protocols such as sample collection procedures, data management issues, and possible subject threats
* Clinical and laboratory skills, including the ability to perform phlebotomy and process samples are preferred
* Detail-oriented and meticulous in all aspects of work
* Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative
* Superior organizational and time management skills
* Capable of working independently with minimal supervision and as part of a team
* Understanding of medical terminology as well as standard clinical procedures and protocol
* Ability to lift approximately 20 pounds for a short period and capable of standing for extended periods of time
Additional Qualifications:
* Strong Project Management skills including risk assessment and contingency planning
* High level of collaboration, customer-oriented awareness, and focus
* Skilled with standard computer programs including the MS Office suite
* Strong interpersonal and written and verbal communication skills
* Therapeutic experience in alignment with primary protocol(s) and site practice preferred
* Some travel may be required
Pay Range:
The combined pay range for this role is $28 - $36/hour. Title and salary will be based on our assessment of skills and experience relevant to our needs for the role.
SiteBridge Research, Inc. is proud to be an Equal Opportunity Employer providing employees with a work environment free of discrimination and harassment. We respect and seek to empower each individual and value the diverse cultures, perspectives, skills and experiences within our workforce. We celebrate diversity and do not discriminate based on race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability status, or any other applicable characteristics protected by law. All employment decisions at SiteBridge are based on business needs, job requirements and individual qualifications and performance.
Clinical Research Coordinator I
Clinical research coordinator job in Lexington, MN
Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.
The Lurie Center for Autism, a Mass General Brigham program based in Lexington, is a multidisciplinary program designed to evaluate and treat children, adolescents and adults with autism spectrum disorder (ASD) and other neurodevelopmental disorders. The Center is seeking a Research Coordinator I to implement a portfolio of clinical research trials and projects related to ASD.
The Clinical Research Coordinator I will work under the supervision of the Senior Clinical Research Program Manager, with direction by the Principal Investigators on specific protocols, and will participate in tasks related to all phases of the clinical research including the development, initiation, monitoring, completion, and reporting phases. All activities will be conducted in accordance with Standard Operating Procedures (SOP) and Good Clinical Practices (GCP) Guidelines.
Job Summary
Summary
Following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc.; maintaining and updating data generated by the study. Candidates who are in the process of completing their bachelor's degree have a grace period of six months from their hire date (up to 1 year if starting per diem) to provide degree equivalency verification.
Does this position require Patient Care?
No
Essential Functions
* Reviews proposals for compliance with sponsor and organizational guidelines; verify all sponsor requirements are met.
* Recruiting patients for clinical trials, conducts phone interviews.
* Verifies the accuracy of study forms and updates them per protocol.
* Prepares data for analysis and data entry.
* Documents patient visits and procedures.
* Assists with regulatory binders and QA/QC Procedures.
* Assists with interviewing study subjects.
* Assists with study regulator submissions.
Qualifications
Education Bachelor's Degree Science required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Some relevant research project work 0-1 year preferred Knowledge, Skills and Abilities - Careful attention to detail and good organizational skills. - Ability to follow directions. - Good interpersonal and communication skills. - Computer literacy. - Working knowledge of clinical research protocols. - Ability to demonstrate respect and professionalism for subjects' rights and individual needs.
Additional Job Details (if applicable)
Remote Type
Onsite
Work Location
1 Maguire Road
Scheduled Weekly Hours
40
Employee Type
Regular
Work Shift
Day (United States of America)
Pay Range
$19.76 - $28.44/Hourly
Grade
5
At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.
EEO Statement:
The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************.
Mass General Brigham Competency Framework
At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
Auto-ApplyClinical Research Coordinator - Comprehensive Cancer Center
Clinical research coordinator job in Rochester, MN
Don't miss this chance to join a world-class team and make a difference in the lives of millions of patients. Apply today and become part of the Mayo Clinic Experience.
As a Clinical Research Coordinator, you will:
Independently coordinate complex (i.e. interventional, therapeutic greater than minimal risk) clinical research protocols with minimal direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines.
Collaborate with research team to assess feasibility and management of research protocols.
Ensure implementation of research protocols after IRB approval and provide information as appropriate for progress reports.
Screen, enroll, and recruit research participants.
Coordinate schedules and monitor research activities and subject participation.
Identify, review, and report adverse events, protocol deviations, and other unanticipated problems appropriately.
Manage, monitor, and report research data to maintain quality and compliance.
Provide education/training for others within the department.
Perform administrative and regulatory duties related to the study as appropriate.
Perform Protocol Development and Maintenance Activities Responsibilities, which may include, but are not limited to: ongoing management of the protocol document and process through editing, amendments, proofing, coordination of study logistics (i.e. blood collection kits, data collection booklets, use of CRU, etc.), and verification of content to meet institutional and federal standards; communication with study sites and/or federal agencies regarding study status changes; Federal and Institutional Review Board (IRB) document preparation and submission; and provides consultative expertise regarding regulatory and policy requirements.
Accurately apply investigators' scientific data into a cohesive format for the protocol document and associated procedures that are consistent with internal and external policies and regulatory requirements.
Participate in other protocol development activities and execute other assignments as warranted and assigned.
*Some travel may be required.
**This position may have the option of working hybrid after some time, requiring the candidate to be within reasonable driving distance of the Rochester, MN campus.**
**Visa sponsorship is not available for this position. This position is not eligible for F-1 OPT STEM extension.**
**During the selection process you will participate in an OnDemand (pre-recorded) interview that you can complete at your convenience. During the OnDemand interview, a question will appear on your screen, and you will have time to consider each question before responding. You will have the opportunity to re-record your answer to each question - Mayo Clinic will only see the final recording. The complete interview will be reviewed by a Mayo Clinic staff member and you will be notified of next steps. **
HS Diploma with at least 5 years of clinical research coordination/related experience OR
Associate's degree/college Diploma/Certificate Program with at least 3 years of experience OR
Associate's in Clinical Research from an accredited academic institution without experience OR
Bachelor's with at least 1 year of experience or completion of a Mayo Clinic-sponsored clinical research internship in lieu of 1 year of experience.
Experience should be in the clinical setting or related experience.
Additional Qualifications
Graduate or diploma from a study coordinator training program is preferred.
One year of clinical research experience is preferred.
Medical terminology course is preferred.
Auto-ApplyClinical Research Coordinator, RN
Clinical research coordinator job in Appleton, WI
Why You Should Work For Us: HealthCare Support Staffing, Inc. (HSS), is a proven industry-leading national healthcare recruiting and staffing firm. HSS has a proven history of placing talented healthcare professionals in clinical and non-clinical positions with some of the largest and most prestigious healthcare facilities including: Fortune 100 Health Plans, Mail Order Pharmacies, Medical Billing Centers, Hospitals, Laboratories, Surgery Centers, Private Practices, and many other healthcare facilities throughout the United States. HealthCare Support Staffing maintains strong relationships with top providers in healthcare and can assure healthcare professionals they will receive fast access to great career opportunities that best fit their expertise. Connect with one of our Professional Recruiting Consultants today to see how a conversation can turn into a long-lasting and rewarding career!
Job Description
Oncology clinical research coordinator will function independently and interdependently in collaboration with the clinical research nurse and other health care providers to promote ethical clinical practices in the conduct of clinical investigations.
The coordinator must demonstrate an in-depth knowledge of federal regulations and guidance documents for the conduct of clinical trials to ensure human subject protection, compliance with protocol and regulatory requirements and the thorough collection, recording and maintenance of data and source documentation.
Completion of regulatory and compliance forms, tracking of research training for participating specialty clinics, and maintenance of other research projects within the system, EPIC research module, and tracking and shipment of all protocol related submissions.
This role functions to assist the clinical research nurse with care coordination of research patients and the research team in coordinating and facilitating the activities of all participants.
Qualifications
Minimum of 1-2 years of Hospital or Clinic experience required.
Oncology experience
Society of Clinical Research Associate Certification (SOCRA) or Certified Clinical Research Professional Certification (CCRP).
Bachelors degree in health sciences preferred.
Clinical research experience, familiarity with federal regulations, GCP, HIPAA and IRB regulations.
Additional Information
Shifts: M-F / day time shift
Length of Assignment: 13 weeks then Right to Hire
Pay Rate: TBD
Clinical Research Coordinator Salaried
Clinical research coordinator job in Oconomowoc, WI
The Clinical Research Coordinator I oversee the conduct of clinical research investigations involving patients and community participants. Employee possesses an in-depth knowledge of federal regulations and guidance for the conduct of clinical trials and human subject protection, assuring compliance with protocol and regulatory requirements, and by collecting, recording, and maintaining data and source documentation.
This position is located in Oconomowoc, WI.
Assist in research planning, design and implementation including the development of standard operating procedures (SOPs), research forms and source documentation tools.
Coordinate and participate in recruitment activities, subject enrollment, and follow-up procedures for multiple research protocols.
Using proper laboratory and phlebotomy technique, ensure appropriate specimen collection, processing, and shipping as required per protocol.
Maintain compliance with GCP guidelines for the conduct of research including study documentation and subject confidentiality/privacy.
Prepare for, schedule, and participate in meetings with research sponsors, contract research organizations (CROs), government and other regulatory entities.
Obtain and manage regulatory and Institutional Review Board (IRB) approvals and communications.
Demonstrate an understanding of research regulatory compliance and participate in educational opportunities to increase research involvement and awareness of regulations, policies, and study activities.
Collaborate with Research Center staff and other departments in order to accomplish research goals.
Promote a team atmosphere by treating individuals with respect and honesty and by using direct communication and active listening skills.
Be open to change and actively support change; Be open to others' ideas and points of view; Adhere to following policies and procedures for Rogers.
Promote department goals as well as the mission of Rogers.
Demonstrate measurable goal achievement; Adhere to department policies and procedures; Resolve individual issues with peers in a positive, solutions focused manner; Include requirements and guidelines from external agencies (i.e., Joint Commission, State of Wisconsin).
Participate in Roger's committees, performance improvement team meetings, and team projects, as directed.
A. Demonstrate punctuality and preparedness.
Demonstrate organizational skills that promote timely response to all inquiries and to task completion.
Communicate with all individuals in a positive and professional manner.
Attempt to resolve individual issues with peers in a positive, calm manner, with a focus on solution.
Communicate concerns and provide solutions for same.
Project a professional image by wearing appropriate, professional attire.
Additional Job Description:
This position is located in Oconomowoc, WI.
Education/Training Requirements:
Associates degree in behavioral science, nursing or a related field required. Bachelor's Degree preferred. [LPN or CNA and minimum (3) three years of research experience may be considered in lieu of advanced degree requirements.]
Minimum of three (3) years of work experience in a clinical or research setting.
Competence in research methodologies and knowledge of clinical protocols; Analytical skills and the ability to resolve technical or research problems and issues; experience working with IRBs.
Preferred phlebotomy certificate and ability to perform EKGs and obtain vital signs.
Proficient with various computer software programs, hardware devices, and ability to learn laboratory equipment.
Completion of applicable research training certification through CITI or comparable program. May be completed within first 30 days of employment.
American Heart Association Healthcare Provider CPR certification or American Red Cross Professional Rescue is preferred and may be required within thirty (30) days of hire.
Formal training in management of the aggressive patient is required within sixty (60) days of date of hire. Annual re-certification is required.
With a career at Rogers, you can look forward to a Total Rewards package of benefits, including:
Health, dental, and vision insurance coverage for you and your family
401(k) retirement plan
Employee share program
Life/disability insurance
Flex spending accounts
Tuition reimbursement
Health and wellness program
Employee assistance program (EAP)
Through UnitedHealthcare, UMR and HealthSCOPE Benefits creates and publishes the Machine-Readable Files on behalf of Rogers Behavioral Health.
To link to the Machine-Readable Files, please visit
Transparency in Coverage (uhc.com)
Auto-ApplyResearch Coordinator
Clinical research coordinator job in Fond du Lac, WI
Circuit Clinical is on a mission to transform how people find, choose, and participate in clinical research. We are challenging the historical clinical trial methodologies through our work focused on improving access and inclusion in community-based healthcare and through our services that unburden the patients and principal investigators participating in research.
We seek a Research Coordinator to join our Team!
As an emerging startup in Buffalo, where New York state fosters rapid and robust growth within the startup community, Circuit Clinical was ranked 20th nationally for Best Workplaces for Innovators by Fast Company and was named an Inc. Magazine Best Workplaces 2021. Circuit's accolades continued beyond the early years as a research industry watchlist company, including winning SCOPE's Participant Engagement Award in 2022 while continuing to receive national recognition as Fast Company's World Changing Ideas Award 2022. Over the past year, Circuit has remained committed to breaking the norms that have challenged research participation and continues to extend reach within the research industry, having expanded client relationships with multiple pharmaceutical companies and contract research organizations. And we are not done yet. Our growth knows no bounds as we extended our community-based research into the Midwest during 2023 while growing our remote research capabilities across all 50 US states.
Our award-winning culture is grounded in our values, the heart of the Circuit ethos. We focus on building an incredible, hard-charging Team and providing them the opportunity to do the best work of their careers. In short, we're motivated to take on the most challenging problems in developing new medicines - this is work that matters to us and those we serve, the patients.
We must recruit the industry's most dynamic, mission-driven, empathetic, and passionate leaders to accomplish our mission. That's where you come in!
What We Offer
Suppose you've been looking for a chance to work with a unique, highly motivated Team and to have a direct impact in building a transformative clinical trials company every day. In that case, that is precisely what we're offering. We provide competitive benefits and an environment focused on helping you grow personally and professionally.
What You Will Bring to Our Team
As our Research Coordinator you will be responsible for coordinating, facilitating, and monitoring the implementation of research study protocols being conducted in accordance with departmental policy, institutional policy, sponsor requirements, and FDA regulations. You will also provide, manage, and coordinate care for patients participating in clinical trials in compliance with written study protocols. You will report to the Regional Site Director and work in collaboration with the Clinical Operations, Regulatory, and Business Development teams.
Requirements
How Will You Do This
Specific responsibilities include:
* Having thorough knowledge of study protocol, including inclusion and exclusion criteria and confirmation of subject eligibility
* Knowledge of study endpoints, reportable events (Adverse Event, Serious Adverse Event, Adverse Events of Special Interest)
* Knowledge of disease process and standard of care
* Completion of study screen tool and study summary
* Defining methods of subject identification and recruitment
* Thorough knowledge of protocol to conduct Informed Consent Form process
* Completion of screening procedures, randomization, and subject visits
* Investigational Product dispensing and accountability
* Scheduling of study visits in compliance with protocol(s)
* Preparation and maintenance of source documents and IRB submitted documents for recruitment
* Assisting in recruitment efforts, contacting and identifying potentially eligible participants to screen
* Confirming Primary Investigator review of study visits
* Reviewing Adverse Events and Serious Adverse Event with Primary Investigator within 24 hour of event report to Institutional Review Board (IRB) and sponsor
* Subject retention activities and follow up procedures
* Obtaining consents for amendments where applicable
* Participating in protocol amendment training and updates essential documents accordingly
* Sponsoring monitoring activities, preparation, data clarification
* Weekly review of study status
* Obtaining appropriate certification of required trainings
* Contributing to patient recruitment efforts as business demands require.
* Additional duties as assigned.
Your qualifications include:
* Bachelor's degree required.
* Minimum 1-3 years experience as a Research Coordinator; or one year of RN level nursing, direct patient care in hospital setting or clinical research nurse
* Certification of Clinical Research Coordinator, preferred. If no certification, willing to obtain certification within two years.
* Computer literacy including Microsoft office (Word, Excel), Google suite, and CTMS software a plus.
What Makes You a Good Candidate
* You are proactive. When problems arise, you think through them logically and with clarity, surface them rapidly and collaborate to resolve them swiftly.
* You are results oriented and see projects through to the finish line without losing momentum - you are comfortable connecting with others at all levels of the organization to help drive a culture of accountability and performance.
* You are an excellent communicator, both verbally and written. You will need to clearly articulate the business, vendor and customer needs and provide status updates to leadership.
* You like to ask questions. You understand the need to obtain drilled down details to have smooth operating success. You can live in those details without losing sight of the bigger picture and the result.
* You are collaborative and work well in a team environment.
* You practice accountability - taking ownership for your work and results.
* You are readily transparent and share pertinent information in a timely manner.
* Your organizational skills are top notch and have a good sense of project management and follow-through.
* You prioritize well but can continually shift priorities based on business needs.
Who You Are
We prize 4 traits above all others:
Hungry: we like people who are ambitious for themselves AND for our Mission and for each other - will all win together and that takes real drive
Happy: we seek pragmatic optimists - pessimism and ironic dispositions, especially in leadership can kill startups - we seek those who know the world can be improved by those who work hard and work smart to change it
Humble: not the false "I'm not really anything" kind of modesty - we like swagger! But we prize people who are confident and know they are great, and so is everyone around them, and we act accordingly
Smart: there are a LOT of smart people here, but smart is last for a reason. We want the kind of smart people who can collaborate and respect the intelligence of others.
The Other Fine Print:
Location: This is a fully on-site position.
Travel: Will be asked to travel to other sites, up to 25% travel expectations
Exemption Status: Full time, exempt
Physical Requirements: the following physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions: Regularly required to sit, walk, and stand use hands; reach with hands and arms; talk and hear. Specific vision abilities include close vision. Other duties: the duties and responsibilities described are not a comprehensive list and that additional tasks may be assigned to the employee from time to time; or the scope of the job.
Salary Description
$70,000 - $85,000
Research Project Coordinator
Clinical research coordinator job in Duluth, MN
Building Location:6th Ave BuildingDepartment:1019992 RESEARCH OPERATIONS - EIRHJob Description:This position will work with American Indian youth in International Falls and surrounding area on substance use prevention activities that embrace Traditional American Indian cultural practices. The ideal candidate will be familiar with American Indian culture and Tradition.
Works closely with Principal Investigators and others to facilitate completion of a variety of research studies within the Essentia Institute of Rural Health. Responsible for the collection and synthesis of data from multiple sources needed to develop reports for research professionals. Develops and monitors project timelines. Coordinates the preparation of manuscripts, abstracts, and other publication and poster presentations related to scientific results. Excellent interpersonal skills and effective performance required to maintain productivity, working relationships, and to enhance image of the organization.
Experience :
Experience in research (health research, public health practice, or similar areas).Education Qualifications:
Bachelors degree required in health care, health science, or research related field.
Licensure/Certification Qualifications:
Bachelors degree required in health care, health science, or related field.
Experience working with American Indian youth or adults strongly preferred.
FTE:0.8
Possible Remote/Hybrid Option:
HybridShift Rotation:Day Rotation (United States of America) Shift Start Time:8:00 AMShift End Time:4:30 PMWeekends:Holidays:NoCall Obligation:NoUnion:Union Posting Deadline:
Compensation Range:
$20.86 - $31.29Employee Benefits at Essentia Health: At Essentia Health, we're committed to supporting your well-being, growth, and work-life balance. Our comprehensive benefits include medical, dental, vision, life, and disability insurance, along with supplemental options to fit your needs. We offer a 401(k) plan with employer contributions to help you plan for the future, and we invest in your professional development through training, tuition reimbursement, and educational programs. To help you thrive both at work and at home, we provide flexible scheduling, generous time off, and wellness resources focused on your physical, mental, and emotional health. Please note that benefit eligibility may vary. For full details, refer to your benefit summary or contact our HR Service Center at **************.
Auto-ApplyStudy Coordinator
Clinical research coordinator job in Washington, MN
The Talent Acquisition department hires qualified candidates to fill positions which contribute to the overall strategic success of Howard University. Hiring staff "for fit" makes significant contributions to Howard University's overall mission. At Howard University, we prioritize well-being and professional growth.
Here is what we offer:
* Health & Wellness: Comprehensive medical, dental, and vision insurance, plus mental health support
* Work-Life Balance: PTO, paid holidays, flexible work arrangements
* Financial Wellness: Competitive salary, 403(b) with company match
* Professional Development: Ongoing training, tuition reimbursement, and career advancement paths
* Additional Perks: Wellness programs, commuter benefits, and a vibrant company culture
Join Howard University and thrive with us!
***************************************
JOB PURPOSE:
To coordinate study participants in the Clinical Trials Unit. Execute tasks as required by the study
protocols.
SUPERVISORY AUTHORITY:
Involves no responsibility or authority for the direction of others.
NATURE AND SCOPE:
Interacts with physicians, immediate staff members, research participants, and the general public.
PRINCIPAL ACCOUNTABILITIES:
* Maintain familiarity with the protocol. Evaluate study candidates for eligibility into the study.
* Meet with the patient's caretaker to review the details of study enrollment.
* Assure that informed consent has been obtained from the patient's legal guardian and consent from the patient when applicable prior to the initiation of research-related activities.
* Schedule tests and appointments for patients within appropriate timeframes.
* Send the prescriptions for study medication to the research pharmacist, including the height, weight or body surface area.
* Identifying abnormal laboratory results and obtain repeat evaluations are required by the protocol.
* Complete case report forms accurately and thoroughly and enter data electronically.
* Maintain source documentation in shadow files for each study participant.
* Respond to date inquiries in a timely manner.
* Complete Serious Adverse Even Reports within the proper timeframes.
* Report to the Project Director and the Principal Investigator regarding assignments and duties.
* Perform other duties as instructed by the Principal Investigator and Project Director.
CORE COMPETENCIES:
* Knowledge of clinical trials protocols.
* Knowledge of management regulations of Howard University.
* Knowledge of the educational and research goals of grant.
* Knowledge of federal and Howard University grant policies, administration and regulation.
* Excellent skill in the operation of desktop computer and software applications to include e-mail and
* calendar functionality, word processing, spreadsheet applications and presentation software.
* Competence in both oral and written English to communicate in a clear and concise manner.
* Ability to establish and maintain effective and harmonious work relations with faculty, staff, students and customers.
*
MINIMUM REQUIREMENTS:
Minimum of a Bachelor of Science degree. Course study concentration in a health-related field is desirable.
Compliance Salary Range Disclosure
$50,000-$60,000
Auto-ApplySenior Clinical Research Coordinator
Clinical research coordinator job in Washington, MN
This role will coordinate research in an exciting new environment, with the full backing of a new type of research architecture and a top-tier technology team, challenging the paper-heavy, old-school way that studies are run. This role will require the desire to learn and grow rapidly, and include the opportunity to help spearhead on-site efforts for Topography's partner healthcare groups. This role will be evaluated on provider success, patient experience, protocol management and adherence, and data quality. This role will require a track record of excellence as a Research Assistant or CRC or other similar role, including developing successful relationships with providers. You will need to be able to thrive with multiple balls in the air, and where independent problem solving is a daily need. You will need to lead with empathy for patients, and care deeply about creating new access to clinical research in communities across the country.
KEY RESPONSIBILITIES
Act as senior study coordinator to execute trials conducted within physician practices, including but not limited to:
a. Visit preparation activities
b. Visit follow-up activities
c. Supply and inventory management
d. Third party vendor management
Conduct patient recruitment and enrollment of eligible patients.
Lead patient study visits, which may also include clinical and lab procedures such as ECG, phlebotomy, vitals signs and body measurements, laboratory processing, etc. 4. Independently administer the informed consent process with care and quality 5. Ensure protocol adherence and high data integrity
Provide high quality source data capture and documentation
Support study start-up and planning, including PSVs and SIVs
Support IRB submission and correspondence
Facilitate monitoring visits (IMVs) and sponsor correspondence including managing the follow-up process
IP management, dispensation and accountability
Adverse Event management, tracking, and follow-up
Data entry to CRF/EDC and query resolution in a timely manner
Support study close-out, including COVs
Protocol deviation tracking, reporting, and reconciliation
Train and mentor junior research staff
Using and helping improve Topography's proprietary tool set
Data Quality-understand and comply with all regulations, policies, and guidelines applicable to clinical research, including our SOPs
Ensure adherence to study protocols while ensuring trial staff maintain meticulous accuracy in completing all documentation
Conduct Quality Control activities including routine QC checks during and following study visits
Any other duties assigned by manager
MINIMUM QUALIFICATIONS
Bachelor's degree or equivalent combination of training and experience
Ability to be on site 5 days a week in Chevy Chase, MD
5+ years of experience as a Clinical Research Coordinator, Research Assistant, or other similar role
5+ years of experience independently coordinating studies, from study startup to close out
5+ years demonstrated track record of delivering clean data and a high-quality patient experience
Expert knowledge of FDA regulations and ICH/GCP guidelines
Strong communication skills, teamwork, cooperation, self-awareness, and flexibility
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
OUTPATIENT CLINIC COORDINATOR - OPERATING ROOMS
Clinical research coordinator job in Two Harbors, MN
Compassion. Accountability. Collaboration. Foresight. Joy. These are the Aspirus Core Values; and we are looking for the BEST around to join us as we demonstrate those values Every. Single. Day. ASPIRUS LAKE VIEW HOSPITAL in Two Harbors, MN is seeking a OUTPATIENT CLINIC COORDINATOR to join our OPERATING ROOMS team!
Salary Range: $19.71 - $28.57 Hourly
Schedule/Hours: DAY ONLY, 8 hours
Weekend Requirement: Generally No Weekends
FTE: FULL TIME, 1.000000 FTE
Off Premise On-Call: No
JOB SUMMARY
The Outpatient Clinic Coordinator assists the physicians and nurses/technicians, if present, in a variety of duties including both secretarial type duties and hands-on assistance with patient care as needed. Locates patient records, readies patients for physician, performs blood pressure checks, height and weight, pulse, eye checks, and calls reports to patients if assigned. All employees are required to adhere to safe work practices and take active part in the AWAIR (A Workplace Accident and Injury Reduction) Program as requested. All employees shall actively support and participate in the Quality Assurance Program.
MINIMUM QUALIFICATIONS
* Education: Completion of Certified Nursing Assistant (CNA) program or Health Unit Coordinator (HUC) program or one (1) year certificate from college or technical school in business related program; or (see Experience).
* Experience: Six (6) months CNA, HUC or related experience; or eighteen (18) months equivalent combination of education and experience.
* Licensure/Certification/Registration: N/A
PREFERRED QUALIFICATIONS
* Education: N/A
* Experience: N/A
* Licensure/Certification/Registration: Certified Nursing Assistant certificate or Health Unit Coordinator certificate.
KNOWLEDGE, SKILLS AND ABILITIES
Good typing skills and computer experience with word processing programs. Ability to prioritize work, handle stressful situations and have good communications skills with co-workers and the general public. Ability to maintain patient and client confidentiality.
* Reading: Intermediate
* Writing: Intermediate
* Speaking: Intermediate
* Mathematical Skills: Basic
* Reasoning Ability: Intermediate
PHYSICAL DEMANDS AND ENVIRONMENT
PHYSICAL DEMANDS
Ability to talk, hear, and stand; walk; use hands to operate a computer keyboard, mouse or telephone keypad; finger, handle, or feel objects, tools, or controls; and reach with hands and arms, to sit and stoop, kneel, or crouch. Ability to lift and/or move up to twenty-five (25) pounds. Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.
* Stand - Occasionally Under 1/3 (1-2.5 hours)
* Walk - Occasionally Under 1/3 (1-2.5 hours)
* Sit - Continuously Over 2/3 (5.5 - 8 hours)
* Use hands to finger, handle, or feel - Continuously Over 2/3 (5.5 - 8 hours)
* Reach with hands and arms - Occasionally Under 1/3 (1-2.5 hours)
* Stoop, Squat, Kneel, or Crouch - Occasionally Under 1/3 (1-2.5 hours)
* Bending-repetitive forward - Occasionally Under 1/3 (1-2.5 hours)
* Talk or hear - Continuously Over 2/3 (5.5 - 8 hours)
LIFTING REQUIREMENTS
* Up to 10 pounds - Frequently 1/3 to 2/3 (2.5 - 5.5 hours)
* Up to 25 pounds - Occasionally Under 1/3 (1-2.5 hours)
WORK ENVIRONMENT
Typical Noise Level - Moderate noise (examples: business office with computers and printers, light traffic)
WORKING CONDITIONS:
Occasionally exposed to toxic or caustic chemicals and blood borne pathogens; moving mechanical parts, fumes or airborne particles and risk of electrical shock. The noise level in the work environment is usually moderate.
This job description is not intended and should not be construed to include all accountabilities, performance measures, knowledge, skills and abilities associated with the job. It is intended to reflect on the critical job elements essential for performing the job.
Employee Benefits
* Full benefits packages available for part- and full-time status.
* PTO accrual from day one!
* Generous retirement plan with match available.
* Wellness program for employees and their families.
Aspirus Lake View Hospital is a 15-bed critical access hospital located on the scenic North Shore of Lake Superior. This facility combines the close-knit care of a rural hospital with access to the robust resources of the Aspirus Health system. In addition to hospital-based services, the Lake View campus includes a full-service primary care clinic, emergency services, imaging, lab, rehabilitation, and outpatient specialty care. Aspirus Lake View is an essential part of the Two Harbors community and surrounding Lake County, providing residents with compassionate, comprehensive care just steps from home. Two Harbors, MN
Our Mission: We heal people, promote health and strengthen communities.
Our Vision: Aspirus is a catalyst for creating healthy, thriving communities, trusted and engaged above all others.
As an Aspirus team, we demonstrate caring, we plan to impact the future, work with happiness and enthusiasm, recognize our power to make a difference and improve the health of our communities.
Aspirus Health is a nonprofit, community-directed health system based in Wausau, Wisconsin, serving northeastern Minnesota, northern and central Wisconsin and the Upper Peninsula of Michigan. The health system operates 18 hospitals and 130 outpatient locations with nearly 14,000 team members, including 1,300 employed physicians and advanced practice clinicians. For more information visit aspirus.org.
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Clinical Research Coordinator - Germantown, WI - Part-Time
Clinical research coordinator job in Germantown, WI
SiteBridge Description:
Founded in 2021, SiteBridge Research is a community-focused integrated research organization, building a national network of community practices to deliver world-class industry sponsored clinical research on time and on budget, accelerating time to market and product adoption in communities that are the most vulnerable and the hardest to reach. The SiteBridge network extends reach further into these communities to empower a broader set of patients with some of the highest unmet needs to take part in clinical research to improve health outcomes.
Job Description: Clinical Research Coordinator/Research Nurse - Contractor
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Clinical Principal Investigator (PI) on multiple ongoing research studies. While the Principal Investigator is ultimately responsible for the clinical trial, the CRC is responsible for the facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study. The CRC works collaboratively with the entire site team, sponsors, and clinical monitors to ensure ICH/GCP compliance, site productivity, and timely completion of studies. In addition, and most importantly, this role represents our mission and vision by focusing on the trusted physician/patient partnership from start to finish for every clinical trial conducted at the site and is key in transforming clinical research for every participant. The position will be responsible for specific clinical site activities to maintain the operational excellence required of clinical sites/staff involved in clinical studies and to assure compliance with protocol-specific procedures, data acquisition, and records management. This role will report to the Director, Clinical Site Development Operations and Study Management.
Location: The position is located in Germantown, WI and will be required to be on-site.
Job Type: This is an (1099) Independent Contractor position and is part-time to begin with potential to move into full-time based on study needs.
Responsibilities:
Ensure clinical study compliance with local and federal laws and regulations according to ICH/GCP Guidelines
Ensure study feasibility assessments for contracted sponsor-initiated studies
Assist the Clinical/Site Ops Leads on the set-up/start-up of research site to prepare for start-up and conduct of clinical trials
Lead oversight of pre-study, site initiation, and close-out visits with sponsor or CRO
Consult with Site Leads, sponsor, and CRO to determine the best recruitment practices for site and trials
Track study activities to ensure compliance with standard operating procedures (SOPs), protocols, and all related local, state, and national regulatory and institutional policies
Arrange screening and recruitment of potential study participants by scheduling visits to establish Informed Consent and perform intake assessments according to protocols
Create and maintain all essential documents and records related to the study
Act as a point of reference for study participants by answering questions and keeping them informed on the study's progress
Oversee and/or manage the inventory of equipment and supplies related to the study, including documentation, reporting of issues, and ordering clinical supplies as needed
Communicate with laboratories and clinical investigators to ensure review and reporting of lab results and other clinical testing results
Direct the request, collection, labeling, storage, or shipment of interventional products
Ensure collection of specimens, questionnaire information, and input of data and patient information into electronic clinical systems
Monitor the enrollment status of participants at the site for each specific clinical study
Operate as primary contact for sponsors/CROs to schedule and coordinate site visits and answer queries
Participate in meetings (Investigator Meetings, Site Trainings, etc.) and seminars to update knowledge of clinical research and related issues
Prepare or participate in quality assurance audits and inspections performed by sponsors/CROs, regulatory authorities, or exclusively designated review groups
Provide regular updates to Site Clinical Investigator(s) and Clinical/Site Ops Leads on study progress related to recruitment, compliance, and other study-related matters
Qualifications & Required Experience:
Candidates with pediatric experience strongly encouraged to apply.
Bachelor's degree in a relevant life science discipline is preferred; LPN/RN is preferred; certification as CCRC/CCRP is a plus; Education requirement exceptions can be made based on relevant clinical research experience
Minimum 1 year of experience in clinical research. Number of years of previous experience working in a clinical research setting; number of years of clinical site/trials experience will determine position level
Excellent working knowledge of FDA & ICH GCP regulations and guidelines is required
Strong preference for experience with late-phase and observational clinical research
Managing necessary clinical study and staff records related to clinical study activities including: case report forms, drug dispensation records, etc.
Preparing advertising and other educational materials and conducting campaigns to recruit and enroll subjects
Preparing trial-related document support such as protocol worksheets, adverse event reports, IRB documents, procedural manuals, and progress reports
Experience identifying, reviewing, and reporting adverse events, protocol deviations, or other unanticipated problems appropriately to investigators and/or regulatory agencies
Assessing risk factors in study protocols such as sample collection procedures, data management issues, and possible subject threats
Clinical and laboratory skills, including the ability to perform phlebotomy and process samples are preferred
Detail-oriented and meticulous in all aspects of work
Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative
Superior organizational and time management skills
Capable of working independently with minimal supervision and as part of a team
Understanding of medical terminology as well as standard clinical procedures and protocol
Ability to lift approximately 20 pounds for a short period and capable of standing for extended periods of time
Additional Qualifications:
Strong Project Management skills including risk assessment and contingency planning
High level of collaboration, customer-oriented awareness, and focus
Skilled with standard computer programs including the MS Office suite
Strong interpersonal and written and verbal communication skills
Therapeutic experience in alignment with primary protocol(s) and site practice preferred
Some travel may be required
Pay Range:
The combined pay range for this role is $28 - $36/hour. Title and salary will be based on our assessment of skills and experience relevant to our needs for the role.
SiteBridge Research, Inc. is proud to be an Equal Opportunity Employer providing employees with a work environment free of discrimination and harassment. We respect and seek to empower each individual and value the diverse cultures, perspectives, skills and experiences within our workforce. We celebrate diversity and do not discriminate based on race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability status, or any other applicable characteristics protected by law. All employment decisions at SiteBridge are based on business needs, job requirements and individual qualifications and performance.
Clinical Research Coordinator, RN
Clinical research coordinator job in Appleton, WI
Why You Should Work For Us:
HealthCare Support Staffing, Inc. (HSS), is a proven industry-leading national healthcare recruiting and staffing firm. HSS has a proven history of placing talented healthcare professionals in clinical and non-clinical positions with some of the largest and most prestigious healthcare facilities including: Fortune 100 Health Plans, Mail Order Pharmacies, Medical Billing Centers, Hospitals, Laboratories, Surgery Centers, Private Practices, and many other healthcare facilities throughout the United States. HealthCare Support Staffing maintains strong relationships with top providers in healthcare and can assure healthcare professionals they will receive fast access to great career opportunities that best fit their expertise. Connect with one of our Professional Recruiting Consultants today to see how a conversation can turn into a long-lasting and rewarding career!
Job Description
Oncology clinical research coordinator will function independently and interdependently in collaboration with the clinical research nurse and other health care providers to promote ethical clinical practices in the conduct of clinical investigations.
The coordinator must demonstrate an in-depth knowledge of federal regulations and guidance documents for the conduct of clinical trials to ensure human subject protection, compliance with protocol and regulatory requirements and the thorough collection, recording and maintenance of data and source documentation.
Completion of regulatory and compliance forms, tracking of research training for participating specialty clinics, and maintenance of other research projects within the system, EPIC research module, and tracking and shipment of all protocol related submissions.
This role functions to assist the clinical research nurse with care coordination of research patients and the research team in coordinating and facilitating the activities of all participants.
Qualifications
Minimum of 1-2 years of Hospital or Clinic experience required.
Oncology experience
Society of Clinical Research Associate Certification (SOCRA) or Certified Clinical Research Professional Certification (CCRP).
Bachelors degree in health sciences preferred.
Clinical research experience, familiarity with federal regulations, GCP, HIPAA and IRB regulations.
Additional Information
Shifts: M-F / day time shift
Length of Assignment: 13 weeks then Right to Hire
Pay Rate: TBD
Clinical Research Coordinator
Clinical research coordinator job in Cambridge, MN
Site: The Spaulding Rehabilitation Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.
At Spaulding, we aim to apply the results of research and new ideas to patient care as quickly as possible. As the principal teaching hospital of the Harvard Medical School Department of Physical Medicine & Rehabilitation, new ideas and a passion for innovation are part of our makeup. This academic affiliation and our combined resources allow us to maintain a vigorous research agenda and operate ongoing clinical trials.
These and other endeavors enhance Spaulding's treatment programs, with clinical research results often quickly finding their way to the bedside.
This is a per diem position in the Neuromodulation Lab led by Dr. Felipe Fregni.
Job Summary
Summary
Following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc.; maintaining and updating data generated by the study.
Candidates who are in the process of completing their bachelor's degree have a grace period of six months from their hire date (up to 1 year if starting per diem) to provide degree equivalency verification.
Does this position require Patient Care? No
Essential Functions
* Reviews proposals for compliance with sponsor and organizational guidelines; verify all sponsor requirements are met.
* Recruiting patients for clinical trials, conducts phone interviews.
* Verifies the accuracy of study forms and updates them per protocol.
* Prepares data for analysis and data entry.
* Documents patient visits and procedures.
* Assists with regulatory binders and QA/QC Procedures.
* Assists with interviewing study subjects.
* Assists with study regulator submissions.
Qualifications
Qualifications
Education
Bachelor's Degree Science required
Can this role accept experience in lieu of a degree?
Yes
Licenses and Credentials
Experience
Some relevant research project work 0-1 year preferred
Knowledge, Skills and Abilities
* Careful attention to detail and good organizational skills.
* Ability to follow directions.
* Good interpersonal and communication skills.
* Computer literacy.
* Working knowledge of clinical research protocols.
* Ability to demonstrate respect and professionalism for subjects' rights and individual needs.
Additional Job Details (if applicable)
Remote Type
Onsite
Work Location
1575 Cambridge Street
Scheduled Weekly Hours
0
Employee Type
Per Diem
Work Shift
Day (United States of America)
Pay Range
$19.76 - $28.44/Hourly
Grade
5
At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.
EEO Statement:
The Spaulding Rehabilitation Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************.
Mass General Brigham Competency Framework
At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
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