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.
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 Michigan Medicine CRC Career Ladder is required.
Experience as part of a team with all 8 competency domains is expected:
1.Scientific Concepts and Research Design
2.Ethical Participant Safety Considerations
3.Investigational Products Development and Regulation
4.Clinical Study Operations (GCPs)
5.Study and Site Management
6.Data Management and Informatics
7.Leadership and Professionalism
8.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.
- 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.
- Associate degree in Health Science or an equivalent combination of related education and experience is necessary.
- Minimum 1 year of directly related experience in clinical research and clinical trials is necessary. (Please reviewSoCRA?s Definition of a Clinical Research Professional for qualifying experience prior to applying.)
or
An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, HealthCare Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD.orMinimum 3 years of human subject experience (clinical, lab or health regulations) such
- 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.
Hours/Week: 40 hours
Shift/Hours/Days: Days, occasional evening, potential weekends, potential on call
The University of Michigan is an equal employment opportunity employer.
