What are the responsibilities and job description for the Clinical Research Technician position at University of Michigan Health System?
Job Opening ID
261197
Working Title
Clinical Research Technician
Job Title
Clinical Research Technician
Work Location
Ann Arbor Campus
Ann Arbor, MI
Modes of Work
Hybrid
Full/Part Time
Full-Time
Regular/Temporary
Regular
FLSA Status
Nonexempt
Organizational Group
Medical School
Department
MM Cardiac Surgery
Posting Begin/End Date
3/13/2025 - 4/01/2025
Career Interest
Research
How to Apply
A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.
Job Summary
The REMEDY team at the University of Michigan (UM) manages the vast portfolio of surgical clinical trials for the Department of Cardiac Surgery. The team consists of varying levels of coordinators dedicated to advancing healthcare to improve outcomes for patients. Our collaborators include investigators from other departments within UM, industries, and Universities. We specialize in multi-center, including international, device trials as well as outcomes research, drug trials, and investigator-initiated studies. As we continue to expand our portfolio, we are looking for detail orientated, highly motivated, compassionate individuals to join our team.
This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the CRC-Assistant position on the is required.
Responsibilities*
Experience as part of a team with all 8 competency domains is expected:
- Scientific Concepts and Research Design
- Ethical Participant Safety Considerations
- Investigational Products Development and Regulation
- Clinical Study Operations (GCPs)
- Study and Site Management
- Data Management and Informatics
- Leadership and Professionalism
- Communication and Teamwork
Responsibilities will include, but are not limited to:
- Perform moderately complex study procedures with accuracy.
- Triage simple subject concerns and issues appropriately.
- Assess studies for execution and troubleshoots potential implementation issues.
- Schedule, assist with preparation, and attend study initiation meetings, audits, and monitor visits.
- Complete simple to moderately complex data collection during study visits.
- May assist in CRF development.
- Complete new eResearch applications.
- Maintain essential regulatory documents as outlined in the ICH-GCP guidelines.
- Gather participant approval via informed consent.
- Prepare and participate in internal and external audits.
- Identify Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information or Events (ORIOs), and understands how to report appropriately.
- Communicate with study participants such as sending study correspondence via mail or email.
- Schedule subjects for research visits and FU appointments.
- Check study calendar for completion of study procedures.
- Utilize documents and systems to track recruitment and retention of participants.
- Maintain regulatory binder.
- Gain appropriate training & knowledge of EMR, CTMS, EDC, databases, etc. as assigned.
- Willing to learn and use available technology and systems to accomplish job requirements.
- Understand the disease process per program.
- Attend and participate in all training classes assigned to this level. Assists with training activities of staff and others.
- Perform other related duties as assigned.
Supervision Received:
This position reports directly to the Clinical Trial Lead for the Department of Cardiac Surgery
Supervision Exercised:
None.
Required Qualifications*
- Associate degree in Health Science or an equivalent combination of related education and experience.
- ONE of the following:
- Minimum 1 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's qualifying experience prior to applying.
- An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD.
- Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research.
Desired Qualifications*
- Bachelor's degree in Health Science or an equivalent combination of related education and experience is desirable.
- An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable.
Work Schedule
Hours/Week: 40 hours
Shift/Hours/Days: Days, occasional evening, potential weekends, potential on call.
Modes of Work
Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the .
Additional Information
Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe.
Background Screening
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.
Application Deadline
Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.
U-M EEO Statement
The University of Michigan is an equal employment opportunity employer.
