Clinical Research Associate - NAMSA Future Openings USA
Clinical research associate job in Saint Paul, 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-ApplyPrincipal Clinical Scientist
Clinical research associate job in Maple Grove, MN
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:
Career development with an international company where you can grow the career you dream of.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with a high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of our SH division.
Structural Heart Business Mission: Why We Exist
Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.
As the Principal Clinical Scientist, you'll have the chance to work closely with the clinical study team including project management, biostatistician, data management, and other clinical study personnel. This position will have significant interaction with leadership and regulatory authorities. Furthermore, this position will be required to execute their job responsibilities within the corporate policies and standard operating procedures.
What You'll Work On
Develops, writes, or mentors others in creation of clinical strategy, risk management, or clinical evaluation planning for products and process changes, to gain regulatory approval for product release, additional claims or indications, by addressing issues from a clinical, medical, and scientific perspective and by interacting with appropriate personnel.
Develops, writes, or mentors others in generation of study-related documents and/or contribute content and oversight of such documents, including, but not limited to, clinical study reports, clinical study protocols, case report forms, investigational brochures, and informed consent forms.
Designs or mentors others in the design of clinical trials and studies in collaboration with internal stake holders including clinical project management, clinical operations, biostatistics data management, regulatory affairs, medical affairs as well as external stake holders including steering and publication committees.
Develop the scientific podium and publication strategy in close collaboration with cross-functional teams and lead the execution of the publication strategy through coordination with investigator authors and internal teams.
Serve as an active member of study teams and provide scientific support to justify trial design and ongoing scientific analysis during protocol development. May include generation of pre-protocol documentation of scientific information.
Review and critically analyze statistical analysis plans.
Generate documents to support regulatory submissions for Abbott products and/or respond to questions from regulatory authorities about existing submissions.
Required Qualifications
Advanced degree in the sciences, medicine, or similar discipline.
8+ years of related work experience with a solid understanding of specified functional area, or an equivalent combination of education and work experience.
Demonstrated scientific writing ability.
Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
Independent decision making required.
Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Has broad knowledge of various technical alternatives and their potential impact on the business.
Preferred Qualifications
· PhD in a scientific, medical, or related discipline.
· Experience with regulated and post-market clinical studies.
· Familiarity with quality system environments.
· Strong background in medical device clinical trials.
· Knowledge of MDR requirements and experience developing PMCF Plans/Reports.
· Experience in physician and safety management.
· Prior collaboration with external clinical research committees (e.g., screening committees, DSMB, CEC).
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: **********************
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at *************** on Facebook at ************************ and on Twitter @AbbottNews.
The base pay for this position is
$97,300.00 - $194,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Clinical Affairs / StatisticsDIVISION:SH Structural HeartLOCATION:United States > Maple Grove : 6820 Wedgwood Road N.ADDITIONAL LOCATIONS:United States > Santa Clara : 4551 Great America ParkwayWORK SHIFT:StandardTRAVEL:Yes, 5 % of the TimeMEDICAL SURVEILLANCE:NoSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: ************************************************************ EEO is the Law link - Espanol: ************************************************************
Auto-ApplyProject Manager, Clinical Data & Performance Reporting (ICTx)
Clinical research associate job in Maple Grove, MN
Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.
About the role:
As a Project Manager within ICTx Clinical Data and Perfomance Reporting, you will play a critical role in driving data-informed decision-making across the CT/IHF and SHV/RDN Clinical Trials teams. You will be responsible for developing, automating, and maintaining clinical trial reports and performance dashboards, while also serving as a key technical resource for the Smartsheet platform. This role supports cross-functional collaboration to optimize operational efficiency and ensure timely and accurate insights that support strategic clinical goals.
Work mode, and sponsorship:
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Your responsibilities will include:
* Support the ICTx Clinical Affairs team in developing and maintaining current operational and performance metrics.
* Develop and maintain clinical trial status reports and performance dashboards for CT/IHF and SHV/RDN Clinical Trials teams.
* Provide training and technical support for Smartsheet, the core reporting platform.
* Identify, propose, and implement automation opportunities within the reporting ecosystem.
* Collaborate with cross-functional teams to validate data sources and ensure consistent reporting standards.
* Deliver timely and audit-ready metrics and dashboards for review by internal stakeholders and senior leadership.
Required qualifications:
* Minimum Bachelor's degree in life sciences, data analytics, engineering, or a related field
* Minimum of 5 years' experience in clinical research, project management, or reporting/analytics within healthcare or medical devices
* Proven hands on experience with Smartsheet, Tableau, Power BI, Excel, and SQL
* Strong analytical and data visualization skills with demonstrated experience creating clinical trial performance dashboards.
* Proven and superior communication and stakeholder management skills, including experience translating complex data into clear insights for leadership
* Proven understanding of the clinical trial lifecycle and regulatory/compliance requirements.
Preferred qualifications:
* Preferred Master's degree or PMP certification
* Familiarity with clinical trial management systems (CTMS)and data governance standards
* Prior experience implementing or supporting business intelligence tools in a regulated environment
Requisition ID: 619063
Minimum Salary: $94300
Maximum Salary: $179100
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see ******************************* vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.
Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination.
Nearest Major Market: Minneapolis
Job Segment: Project Manager, Engineer, Clinic, Database, Medical Device, Technology, Engineering, Healthcare
Clinical Research Scientist Interventional Solutions
Clinical research associate job in Saint Paul, MN
Are you looking to make meaningful impact with your research/technical experience? Working daily in close partnership with Interventional key clinical partners - as well as global and local GE Healthcare colleagues - you will be responsible for locally driving the technical and scientific design and execution of collaborative projects, evaluating early developments and generating evidence on new products while providing insights to the global modality on unaddressed clinical needs and growing trends.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
**Job Description**
**Responsibilities**
+ Support collaboration with top Interventional clinical partners, planning and executing pre- and post-market evidence generation research projects per Interventional research priorities.
+ Assist in maturing evidence portfolio (writing journal publications/summary articles, technical documents, clinical marketing/training collaterals) and identifying unique opportunities for partnership (contributing to letters of support, research proposals, supporting identified grant submissions).
+ Support adoption of new technology or clinical applications through advocacy and evidence.
+ Participate in customer presentations regarding use of Interventional products for institution research purposes.
+ Closely connected with GEHC global modality clinical and R&D teams, explore unmet clinical and technical needs with external collaborators and translate to define and prioritize product development needs.
+ Collect data, clinical & product feedback, technical study endpoints, DICOM images and annotations
+ Support customer satisfaction through communication, observation, and escalation of site inquiries/concerns.
+ Grow technology leadership mindshare through joint scientific presentations and publications.
+ Install/upgrade research equipment and software & prototypes
+ Lead GE Interventional solutions evaluation and optimization for emerging interventional procedures
+ Represent the global modality technical, scientific and product expertise in USCAN to support local clinical teams and best-in-class customer experience on new products.
+ Study new technology concepts and leverage expertise to move initiatives forward.
Note:
+ No sponsorship available for this role now or in the future to work in the United States..
**Qualifications**
+ PhD or Master's degree, or foreign degree equivalent, in Medical Imaging, Physics, Computer Science, Biomedical Engineering, or related field.
+ 3+ years of experience in Interventional healthcare industry or research.
+ Knowledge of Interventional procedures, anatomies, clinical practice.
+ Excellent written and verbal communication skills.
+ Excellent customer relationship management and collaboration skills.
+ Demonstrated clear thinking and problem-solving abilities, a creative mindset, and the ability to quickly grasp new ideas.
+ Self-starter, able to work independently and collaboratively with partners clinical staff, GE global engineering team and GE regional clinical teams, results oriented, able to multi-task.
+ Flexible, intellectually curious, and able to work under remote supervision with cross-functional, global teams.
+ Able to individually lead complex projects with autonomy, rigor, drive & competence
+ Ability to travel (
+ Quality, Compliance, and Continuous Improvement focus
**Desired Characteristics**
+ 5 years' experience in an engineering or science field such as Biomedical Engineering, Medical Imaging, Computer Science, Applied Math or Physics.
+ Experience in a clinical environment working with clinicians/radiologists/specialists (e.g. interventional radiology or cardiology department)
+ Demonstrated record of innovation and development.
+ History of publications, clinical/non-clinical experiments, knowledge in statistics
+ Programming / Image processing experience
+ Experience with academic and/or clinical research collaborations
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity.
Our **total rewards** are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.
\#LI-BR3
\#LI-Remote
We will not sponsor individuals for employment visas, now or in the future, for this job opening.
For U.S. based positions only, the pay range for this position is $97,600.00-$146,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.
**Additional Information**
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
**Relocation Assistance Provided:** No
Sr Clinical Research Specialist
Clinical research associate 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
**********************************
************
Easy ApplySenior Clinical Research Monitor
Clinical research associate job in Mounds View, MN
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
Job Title:
Senior Clinical Research Monitor
Location:
Mounds View, MN
Duration:
24+
(possibility of extension)
MANDAOTORY REQUIRED
1)
Device experience
2)
Cardiovascular experience
There is a total of 3 openings and they need 1 candidate in each region below:
Region 1 (NorthEast), Region 4 or 5 (Midwest) and Region 6 (West Coast).
POSITION DESCRIPTION:
·
The Senior Clinical Research Monitor is responsible for the ov
ersight of clinical research conducted at investigational sites to ensure compliance with applicable regulatory standards, IRB/EC policies and procedures and Business requirements.
·
This position works under minimal supervision, working closely with study teams, site personnel, and Healthcare field personnel and monitoring supervisor for resolution of site issues.
·
The Senior Clinical Research Monitor may play a leadership role in managing monitoring activities.
·
POSITION RESPONSIBILITIES:
• Perform site monitoring visits in accordance with the study Monitoring Plan to ensure compliance with the Investigational Plan, Monitoring Plan, applicable regulatory, IRB/EC, and Healthcare standards, guidelines and policies
• Communicate visit findings with site personnel and complete a written letter for distribution to the Principal Investigator and appropriate site personnel for follow-up
• Prepare site visit reports and correspondence for all visits conducted in accordance with the study Monitoring Plan
• Identify site needs, provide solutions to facilitate the clinical trial process
• Act as a primary point of contact for study sites as requested
• Provide input into the development and improvement of investigator and site management systems (e.g., CTMS)
• Assist in initial and ongoing site personnel training as required
• Identification and escalation of protocol deviations, discrepancies in data, and non-compliance to study protocols, applicable regulations, Good Clinical Practices and Standard Operating Procedures
• Propose solutions and collaborate with monitoring management and study team personnel towards securing Investigator compliance.
• Understand the study protocol and accompanying background information (e.g., Investigator Brochure, Report of Prior Investigations etc.)
• Possess a working knowledge of disease state and investigational product
• Possess understanding of regulatory requirements
• Mentor and/or train junior personnel
• Assist sites/study teams with audit preparation
• Adhere to all applicable Healthcare policies and procedures
In addition, the Senior Clinical Research Monitor may:
• Attend Investigator and/or Coordinator meetings
• Prepare meeting presentations and/or deliver training during meetings (Investigator/Coordinator meetings, study/monitoring team meetings, etc.)
• Provide input into final study site selection
• Be involved in site management activities
• Be assigned lead monitor responsibilities which include but are not limited to:
o Providing input on study protocol, CRFs and other study documents
o Authoring Monitoring Plans, monitoring section of Data Management Plans, and source document worksheets
o Assisting in the creation of corrective and preventive action plans and trending reports
o Managing site assignments in collaboration with manager
o Facilitating communication and information flow between assigned project teams and assigned monitors on project
o Ensuring monitors are trained, current with project requirements and understand study milestones
o Overseeing action item tracking and resolution status
o Performing co-monitoring visits as needed
o Ensuring Monitoring Plan requirements are being met and escalates risks
o Attending Core/Study team meetings
BASIC QUALIFICATIONS:
Education Required:
·
Bachelor's Degree in life sciences
,
nursing
or other
health related disciplines
Years Of Experience:
·
Four (4) years clinical research
experience with at
least two (2) years of clinical monitoring
experience or
Master's degree with 2 years
clinical research experience
DESIRED/PREFERRED QUALIFICATIONS
• Cardiovascular experience
• Experience
monitor Device Trials
• Excellent interpersonal skills
• Experience working in a team/matrix environment requiring strong working relationships
• Ability to handle and prioritize multiple therapeutic areas and projects simultaneously
• Ability to work in a fast paced environment
• Competencies and essential skills in the following: cross functional relationships, decision making, execution/results/process improvement, customer satisfaction
• Demonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands.
• High attention to detail and accuracy
• Experience working independently in a regional area with remote or minimal supervision
• Strong leadership skills
• Excellent problem solving skills
• Experience with word
processing, spreadsheets, and databases applications (e.g., MS Word and Excel
)
• Applied understanding of any applicable regulations (e.g., Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive, etc.)
• Business knowledge or experience with the medical / healthcare industry
• Class III medical device and/or phase II, III and IV pharmaceutical experience
• Experience to demonstrate understanding of technical, scientific and medical information
• Experience with Regulatory and Quality Assurance audits
• Experience of conducting clinical research activities in a regulated environment
• Proficient knowledge of medical terminology
• Regulations/standards training (FDA, ISO, GCP and other country specific training, such as for Canada, Asia, Latin American, etc. as applicable)
• Scientific/clinical knowledge needed to adequately monitor the trial (e.g. general therapeutic area education and training)
PHYSICAL JOB REQUIREMENTS:
• The physical demands described within the Responsibilities section of this job description 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 be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.
• Ability to travel up to 80%
• Travel with colleagues and manager as requested
• May require international travel
Additional Information
Feel free to forward my email to your friends/colleagues who might be available.
We do have referral bonus, if you refer any of your friends or colleague who are looking out for the same job.
Thanks & Regards,
Seema Chawhan
Clinical Recruiter
Integrated Resources
, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE
|
GSA - Schedule 66
I
GSA - Schedule 621I
DIRECT # -
732-844-8724
|
LinkedIn:
https://in.linkedin.com/in/seemachawhan
Gold Seal JCAHO Certified ™
for Health Care Staffing
“INC
5
0
0
0
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FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
Clinical Study and Biospecimen Coordinator
Clinical research associate 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
Clinical Trial Coordinator
Clinical research associate 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 /Psychologist
Clinical research associate 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 ApplyClinical Research Spec - Exempt
Clinical research associate job in Mounds View, MN
Join our dynamic team in Mounds View, MN, where innovation meets excellence in clinical research. We are seeking a highly motivated individual to oversee, design, and develop clinical evaluation research studies. This role offers the opportunity to work full-time on-site in a collaborative and cutting-edge environment.
Must Have
Experience with CTMS and patient data and site management systems (i.E., Veeva Vault, RAD Rave, Oracle)
Proficiency in Microsoft Office Applications
Top 3 Candidate Experience Requirements
Site management experience (site or sponsor)
Knowledge/experience with CTMS/EDC/TMF
Experience with Good Clinical Practice (GCP)
Education and Experience
Education Required: Bachelor's Degree (preferably in engineering, life sciences, or related medical/scientific field)
Years of Experience Required: Minimum 2 years of experience
Responsibilities
Responsibilities may include the following and other duties may be assigned:
Oversee, design, plan, and develop clinical evaluation research studies.
Prepare and author protocols and patient record forms.
Conduct registered and nonregistered clinical studies of products that satisfy a medical need and/or offer commercial potential.
Oversee and interpret results of clinical investigations in preparation for new drug device or consumer applications.
Oversee and resolve operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations.
May prepare clinical trial budgets and be responsible for clinical supply operations, site, and vendor selection.
Career Stream
This position typically involves responsibilities in a professional discipline or specialty. The role requires delivering and/or managing projects assigned and collaborating with other stakeholders to achieve desired results. You may act as a mentor to colleagues or direct the work of other lower-level professionals.
Required Knowledge and Experience
The position requires practical knowledge and demonstrated competence within the job area, typically obtained through advanced education combined with experience. A University Degree and a minimum of 2 years of relevant experience are required, or an advanced degree with 0 years of experience.
Clinical Research Coordinator
Clinical research associate 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.
Auto-ApplyResearch Assistant Consultant
Clinical research associate job in Washington, MN
We improve lives The IDB Group is a community of diverse, versatile, and passionate people who come together on a journey to improve lives in Latin America and the Caribbean. Our people find purpose and do what they love in an inclusive, collaborative, agile, and rewarding environment.
About this position
The Research Department (RES) of the Inter-American Development Bank (IDB or the Bank) is seeking a proactive and knowledgeable consultant to support as research assistant in the production of the 2027 Development in the Americas (DIA) report on Demographic Transition and Development in Latin America and the Caribbean (LAC). The report will analyze how demographic changes shape the region's development opportunities and policy challenges.
The research assistant will collaborate closely with the editors of the report and with economists in the Research Department, contributing to a range of analytical and coordination activities. Responsibilities include collecting and organizing relevant demographic and economic data, conducting background research and literature reviews, preparing tables and figures, contributing to presentations, and supporting the overall production process of the report.
You will work under the guidance of the report's editors and in close coordination with chapter authors, external academic advisors, and other contributors. The Research Department is responsible for generating innovative ideas that support the strategic policy agenda of the Bank and its member countries to achieve inclusive and sustainable development in the region. To maximize the impact of its research, the department carries out activities that inform operational teams, governments, the academic community, and public opinion across LAC.
What you'll do
* Provide support in managing the production of the flagship report DIA 2027 on LAC.
* Assist in organizing the workshops in which chapter authors, editors, and external advisors, will discuss the report.
* Identify, compile, and organize relevant databases.
* Assist researchers in the preparation of background research for the report. Perform econometric and statistical analyses.
* Prepare literature reviews.
* Participate in academic discussions on research findings.
What you'll need
* Education: Bachelor's degree in economics, public policy, or other fields relevant to the responsibilities of the role. Master's degree completed or near completion (or an equivalent advanced degree) in economics, public policy, or another related field is highly preferred.
* Experience: At least 2 years of experience in applied research at a recognized university, research center, or government agency. Strong quantitative background. Prospects of engaging in doctoral-level studies preferred.
* Languages: Proficiency in English and one of the other Bank official languages (Spanish, French or Portuguese) is required.
Requirements
* Citizenship: You are a citizen of one of our 48-member countries. We may offer assistance with relocation and visa applications for you and your eligible dependents.
* Consanguinity: You have no family members (up to the fourth degree of consanguinity and second degree of affinity, including spouse) working at the IDB, IDB Invest, or IDB Lab.
Type of contract and duration
International consultant Full-Time, 18 months (up to 48 months).
What we offer
The IDB group provides benefits that respond to the different needs and moments of an employee's life. These benefits include:
* A competitive compensation package.
* Leaves and vacations: 2 days per month of contract + gender-neutral parental leave.
* Health Insurance: The IDB Group provides a monthly allowance for the purchase of health insurance.
* Saving plan: The IDB Group cares about your future, depending on the length of the contract, you will receive a monthly savings plan allowance.
* On-site position with the occasional flexibility of teleworking
* Development support: We offer learning opportunities to boost your professional profile, such as seminars, 1:1 professional counseling, and much more.
* Health and well-being: Access to our Health Services Center that provides preventive care and health education for employees.
* Other perks (country specific): Lactation room, Daycare Center, Gym, Bike Racks, Parking, spouse career support, and others.
Our culture
At the IDB, we work so everyone brings their best and authentic selves to work while finding their purpose. Our people consistently strive for excellence, and we recognize and celebrate the impact of their contributions.
In our efforts to drive innovation, we intentionally include all voices, cultivate a sense of belonging and champion fairness. We welcome individuals from underrepresented groups to join us and share their unique perspectives.
We ensure that individuals with disabilities are provided reasonable accommodations to participate in the job interview process. If you require an accommodation to complete this application, please email us at accommodations@iadb.org.
Associate Clinical Research Coordinator - Comprehensive Cancer Center
Clinical research associate job in Rochester, MN
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.
Auto-ApplyClinical Research Coordinator - Comprehensive Cancer Center
Clinical research associate 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-ApplyOncology Research Nurse
Clinical research associate job in Saint Louis Park, MN
Park Nicollet is looking to hire an Oncology Research Nurse to join our Research and Education team! Come join us as a Partner for Good and help us make an impact on the care and experience that our patients and their families receive every day.
Position Summary:
Independently oversees and provides patient care management and education, or conducts research using sound nursing judgment, critical thinking, and clinical knowledge and skills. Serves as a mentor/resource to other research and education staff Provides clinical consultative, educational and research support. Collaborates with primary care and specialty departments within PNHS Interacts with the community and external customers, and disseminates knowledge and expertise to other health professionals including oral presentations and written manuscripts.
The Metro-Minnesota Community Oncology Research Consortium (MMCORC) is a nonprofit research program sponsored by the National Cancer Institute (NCI) and participating hospitals and clinics. We are a consortium consisting of 25 community hospitals and oncology clinics with over 160 physician members in the Minneapolis/St. Paul metro-area and surrounding communities, extending to the western Wisconsin area. Our programs mission is to bring the advantages of cancer research to the community. MMCORC provides the opportunity for patients and physicians to have access to National Cancer Institute (NCI) and pharmaceutical sponsored clinical trials for all types of adult cancer. This program provides people in our community access to:
The newest therapies available for cancer treatment
Management of treatment side effects and disease symptoms
Studies directed at cancer prevention
Molecular-based precision medicine research
Cancer care delivery research
This position will be based primarily at Methodist Hospital and an affiliated oncology clinic in St. Louis Park, MN with the need to travel to other local sites. Will consider a lower FTE for the right candidate.
Please visit our website for more information about our program:
**************
This Oncology Research Nurse position will work collaboratively with physicians in identifying and managing patients on NCI and pharmaceutical sponsored clinical trials. This position involves direct patient care and involves a strong patient advocacy role.
Additional responsibilities include:
Screens potential patients for protocol eligibility. Presents trial concepts and details to patients, participates in informed consent process, and enrolls patients onto clinical trials.
Coordinates patient care in compliance with protocol requirements.
Distributes investigational drug and provides patient teaching regarding administration. Maintains accurate investigational drug accountability records.
In collaborations with the physician, assesses patients for changes in conditions, adverse events, concomitant medications use, protocol compliance, response to study drug, and thoroughly documents all findings.
Reports adverse drug reactions and protocol deviations to study sponsor, NCI and FDA according to prescribed reporting system.
Responsible for accurate and timely data collection, documentation, data entry, and reporting.
Participates in monitoring and auditing activities and study visits.
Participates in required training and education programs.
Responsible for education of clinic staff regarding clinical research.
Special Knowledge/Skills:
Oncology nursing experience preferred.
Strong critical thinking, assessment, and problem-solving skills.
Understands and applies teaching/learning principles.
Works independently, as well as collaboratively, displaying effective communication skills.
Supportive of team members.
Works in concert with team members and interdisciplinary staff.
Strong prioritization, multi-tasking skills, and ability to handle large workload.
Have a strong drive for results with patient centered focus.
Come join our team of researchers as we bring the advantages of cancer research to the community.
Work Schedule:
M-F 8:00am - 4:30pm
Required Qualifications:
Education, Experience or Equivalent Combination:
BA, BS, AD, in Nursing from a college or university
One to three years of experience as an RN
Licensure/ Registration/ Certification:
Current RN licensure in the state of Minnesota
Knowledge, Skills, and Abilities:
Demonstrates knowledge of age-related growth and development principles necessary to provide appropriate service and assure safety of patients.
This position requires familiarity and compliance with matters of law, regulations and internal policies affecting the employment relationship, (including but not limited to FMLA, ADA, discrimination, and harassment laws).
Proven proficiency in the operation of the following: Personal Computer, Telephone, Fax Machine, Photocopier, Printer, and electronic medical record.
Preferred Qualifications:
Education, Experience or Equivalent Combination:
Master's Degree
Licensure/ Registration/ Certification:
Certification Diabetes Care and Education Specialist (CDCES) preferred for IDC Patient Services position.
Certified Clinical Research Coordinator (CCRC) or other applicable certification preferred for IDC Research position.
Knowledge, Skills, and Abilities:
Strong critical thinking, assessment, and problem-solving skills
Understands and applies teaching/learning principles.
Works independently, as well as collaboratively, displaying effective communication skills.
Supportive of team members
Works in concert with team members and interdisciplinary staff
Strong prioritization, multi-tasking skills and ability to handle large workload.
Benefits:
Park Nicollet offers a competitive benefits package (for eligible positions) that includes medical insurance, dental insurance, a retirement program, time away from work, insurance options, tuition reimbursement, an employee assistance program, onsite clinic and much more!
Auto-ApplyAssociate Psychotherapist | Psychotherapist | Integrated Behavioral Health | Sartell Clinic
Clinical research associate job in Saint Cloud, MN
Find your purpose! Be part of our Integrated Behavioral Health (IBH) team providing outpatient assessment and brief intervention services for patients and families with behavioral health and/or medical needs at CentraCare- Sartell Clinic. The psychotherapist provides diagnostic, psychological, or biopsychosocial evaluation and executes therapeutic treatment toward defined goals. The psychotherapist works to strengthen motivation and commitment to specific change goals through a collaborative, goal-oriented style of communication using motivational interviewing and evidence-based psychotherapy.
Schedule
Full time | 80 hours every two weeks
Monday-Friday from 8 a.m. - 5 p.m.
Integrated Behavioral Health | Sartell Clinic | Sartell
Pay and Benefits
Psychotherapist starting pay begins at $75,254.40 per year; exact wage determined by years of related experience.
Salary range: $68,939.12 - $103,441.54 per year
Salary and salary range are based on a 1.0 FTE, reduced FTE will result in a prorated offer rate
$6,000 hiring bonus for those hired into a Psychotherapist role (with current MN license of LP, LICSW, LMFT, or LPCC)!
Associate Psychotherapist starting pay begins at $71,780.80 per year; exact wage determined by years of related experience.
Salary range: $63,747.33 - $95,642.90 per year
Salary and salary range are based on a 1.0 FTE, reduced FTE will result in a prorated offer rate
Full time benefits: medical, dental, PTO, retirement, employee discounts and more!
Qualifications (Psychotherapist level)
Master's Degree in Psychology, Social Work, Marriage and Family Therapy or related Human Services field required.
State of Minnesota licensure required, need to have one of the following:
The Board of Psychology as a Licensed Psychologist (LP) or the Board of Social Work at Independent Clinical level (LICSW) or the Board of Marriage and Family Therapy as a Licensed Marriage and Family Therapist (LMFT) or the Board of Behavioral Health & Therapy as a Licensed Professional Clinical Counselor (LPCC).
Minimum of one-year experience required.
Requires successful compliance with Minnesota Law, Chapter 372 relating to sexual exploitation of patients by staff providing psychotherapy services.
Qualifications (Associate Psychotherapist level)
Master's Degree in Psychology, Social Work, Marriage and Family Therapy or related Human Services field required.
State of Minnesota licensure required, need to have one of the following:
The Board of Social Work as a Licensed Graduate Social Worker (LGSW) or Licensed Independent Social Worker (LISW) or the Board of Marriage and Family Therapy as a Licensed Associate Marriage and Family Therapist (LAMFT) or the Board of Behavioral Health & Therapy as a Licensed Professional Counselor (LPC).
Full MN licensure (LP, LICSW, LMFT or LPCC) for independent practice is required within 5 years.
Clinical internship experience relevant to the position is preferred.
Requires successful compliance with Minnesota Law, Chapter 372 relating to sexual exploitation of patients by staff providing psychotherapy services
Qualifications (Psychologist)
PhD or PsyD in Clinical or Counseling Psychology is required.
Minimum of one-year experience is required.
Completion of post-doc training year prior to start date preferred
Licensure by the State of Minnesota Board of Psychology as Licensed Psychologist (LP).
Responsibilities as a IBH Psychologist/Psychotherapist at the CentraCare - Sartell Clinic include implementation of the Primary Care Behavioral Health (PCBH) model of care, including triaging urgent needs from community members and providing intervention in same day crisis situations. Provides diagnostic, psychological, or biopsychosocial evaluation and executes therapeutic treatment toward defined goals for patients and families across a life span (ages 0 - 100+). The focus will be on immediate, flexible format (brief intervention), and close collaboration with the medical provider. Orientations such as Motivational Interviewing, Focused Acceptance and Commitment Therapy (fACT) and Acceptance and Commitment Therapy (ACT), Mindful Self - Compassion, and Behaviorism will be emphasized.
To be eligible for the hiring bonus you must be an external candidate who is hired into an eligible full or part time benefited position. Previous employees qualify if they have not worked for CentraCare for at least 9 months at the date of hire. CentraCare pay incentives to include but not limited to, hiring bonuses may be discontinued at any time due to business needs.
CentraCare has made a commitment to diversity in its workforce. All individuals including, but not limited to, individuals with disabilities, are encouraged to apply. CentraCare is an EEO/AA employer.
Auto-ApplyStudy Coordinator
Clinical research associate 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-ApplyClinical Trials Research Assistant
Clinical research associate job in Minneapolis, MN
Job Description
Apply Here: ********************************************************************************
We are seeking multiple outgoing, patient focused individuals to work as Clinical Trials Research Assistant at our Retina Consultants of Minnesota Edina, MN clinic.Responsibilities for an Clinical Trials Research Assistant include:
Coordinate and schedule subject visits within study/subject specific windows per protocol guidelines.
Prepare visit-specific documentation and charts for Clinical Research Coordinator
Observe Coordinator in patient care and management
Assist Coordinator in monitoring subject flow and assist in subject care and management
Observe, assist, collect and record all necessary data for follow up (e.g. adverse events, concomitant medications, etc.) study visits (Phase 2 & 3; NO Gene Therapy)
Transcribe subject study information from source documents to the Electronic Case Report Forms
Administer all mandatory questionnaires to study subjects
Set up, prepare subject, and conduct electrocardiograms (ECG) on subjects as required per study protocol
Promptly request all necessary medical records for Serious Adverse Event Reporting
Process and ship laboratory biological samples for analysis
Perform intraocular pressure checks after injections
Perform trial frame refraction and ETDRS visual acuity testing (For ISTs only, at selected sites)
Inform subjects and obtain written re-consents in regard to ICF's
Required Skills, Abilities and Attributes:
Applicants MUST be personally motivated to provide excellent patient care!
1+ years of clinical trials research assistant experience in a retina or general ophthalmology environment preferred
Knowledge of medical terminology
Be an excellent team player who works cooperatively and respectfully with all doctors, supervisors and co-workers
Displays a desire to perpetually “Learn and Grow”
Efficient and highly accurate user of applicable information technology and health care management systems
High School Degree or GED
We offer excellent compensation and benefits, to include:
Paid Holidays - 7 days per year
Personal Time Off (PTO) - 16 days per year
Health Insurance
Health Reimbursement Account
Health Savings Account
Dental Insurance (free single coverage)
Flexible Spending Accounts
Basic and Supplemental Term Life Insurance (free single coverage)
Long Term Disability (free single coverage)
Long Term Care (free single coverage)
Short-Term Disability
Vision
Annual $250 uniform (scrubs and shoes) reimbursement
About Retina Consultants of Minnesota (RCM):RCM has 9 Minnesota locations - St. Louis Park, Edina, Edina Specialty, Woodbury, Blaine, Duluth, Maplewood, Anoka and Mankato.Everything we do…. every decision we make…takes our Guiding Principles into consideration. Our guiding principles are:
We exist to serve our patients. We will provide the best available medical skills, technology, and service. We will be their advocates. We will care for our patients as if they were members of our family. We will treat our patients with respect, dignity, and kindness.
We are proud of our dedicated staff. We will strive to provide a rewarding career with opportunity for personal and professional growth. We will promote teamwork. We will provide a respectful and safe working environment.
We are humbled that other doctors entrust their patients to our care. We will be available when we are needed. We will promptly communicate the results of patient evaluation and treatment. We will respect the referring doctors' relationships with their patients.
We recognize that we have a responsibility to our community. We will strive to be desire to perpetually “Learn and Grow”
Efficient and highly accurate user of applicable information technology and health care management systems
A good corporate citizen. We will function ethically. We will be prudent in our stewardship of healthcare resources.
Medical advances are critical to our patients. We will remain at the forefront in the search for new knowledge and treatments of retinal disease. We will participate in clinical research. We will share our knowledge with our patients and referring doctors, and with our retinal colleagues around the world.
Clinical Research Assistant II (Part-Time)
Clinical research associate job in Minneapolis, MN
Job Description
Job Title: Clinical Research Assistant II (Part-Time)
Job Code: CRAII, Part Time, Not Benefit Eligible, Non-Exempt
Lead Worker: John Looft
Admin Supervisor: Lindsey Arnold
Project: Wilken CDO - S10061
Summary:
The Center for Veterans Research and Education (CVRE), whose mission is to help support
innovative research and education initiatives that improve the health and well-being of Veterans, is
seeking a Clinical Research Assistant II.
Position Description:
The Clinical Research Assistant II is responsible for assisting the Principal Investigator with the conduct of preparatory work, recruitment of and follow-up with study participants for the RECOVER studies.
Responsibilities:
Major duties and responsibilities include, but are not limited to the following:
Preparing and emailing/mailing recruitment and randomization materials
Fabricate prostheses and orthoses for research and development studies, including novel prototype devices, with direction from Research Prosthetist Orthotists, Clinical Prosthetists Orthotists, Design Engineers, and Principal Investigators in the RECOVER Program.
Assist with research studies including testing of rehabilitation technologies by persons with disabilities, including recruiting, performing informed consent, collecting data relevant to the research questions, data entry, organization, and analysis, and working with clinical staff of the hospital during these studies.
Utilize scanning, CAD and CAM technologies to assist with shape capture.
Manage, organize, and coordinate administrative aspects of the RECOVER Program, including but not limited to preparing vouchers, submitting work orders/maintenance requests, ordering supplies and maintaining inventory, scheduling of rooms and conference calls.
Communicate with Principal Investigator(s) on a regular basis.
Participate in regular meetings reporting progress and/or problems encountered in the conduct of the study.
Provide input to the Principal Investigator and clinical staff of the hospital during planning of future research and development activities.
Perform record-keeping and assist with writing of articles, invention disclosures, and grant proposals relevant to design, fabrication, and testing of new rehabilitation technologies.
Assist with purchasing new equipment and materials and supplies needed for the research and development activities.
Ensure that components of the project are completed in an ethical, scientifically rigorous, and timely manner.
Ensure compliance with safety regulations and that lab specific protocols are established and followed.
Provide administrative support to initiate studies including assisting with preparation of grant applications and IRB submissions.
Other duties as assigned
Applicant must include a cover letter
Minimum Qualifications:
Education: Bachelor's (BA/BS) or above from an accredited college or university in
public health, sociology, psychology, or related allied health field
Experience: 1-3 years of experience required for CRA II or a post-graduate degree.
Licensure/Registration/Certification: None
Preferred Qualifications:
Minimum 1 year of Clinical Research Assistant experience dealing with data collection and data storage, human subject studies, and institutional review board processes preferred.
Knowledge, Skills, and Abilities:
Basic experience with trouble-shooting devices and software settings.
Experience in coordinating multiple task and project elements with differing timelines and completion deadlines.
Demonstrated ability to work effectively both independently and as part of a team.
Excellent oral and written communication skills.
Exceptional attention to detail and organizational skills.
Proficiency in Microsoft Office products including Outlook, Word, PowerPoint, and Excel.
Knowledge of Good Clinical Practices, human subjects' protection, and federal regulations related to clinical research.
Conditions of Employment:
Subject to a criminal and educational background check.
Designated and/or random drug testing may be required.
Regular and predictable attendance is required.
Typical hours fall within standard business hours, work may be required during hours beyond standard business hours, including weekends.
Must be a US citizen
Physical Requirements: The employee must be able to navigate the medical center, use a keyboard, and lift 25 lbs. Reasonable accommodation may be considered in determining an applicant's ability to perform the duties/functions of the position.
Equal Employment Opportunity: Center for Veterans Research and Education does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy), gender identity or status as transgender, national origin, caste, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor protected by federal, state or local law.
Senior Clinical Research Coordinator
Clinical research associate 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.