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.
This position is located within a sports medicine research and musculoskeletal research lab that currently focuses on clinical trials, epidemiology, outcomes, and genetics research on patients with rehabilitation and orthopedic conditions such as rotator cuff tears that cause shoulder pain. This position will primarily work with a large multi-center study on the genetic epidemiology of rotator cuff tears called cuffGEN. This large study will collect patient outcomes and saliva samples to determine the genetic variants associated with rotator cuff tendon disorders. The coordinator will also work on ARC which is a multi-center randomized clinical trial on operative versus non-operative treatment for rotator cuff tears.
Characteristic Duties and Responsibilities Independent knowledge, skills, and abilities within 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
Study Set-Up/ Maintenance
Function as point person for cuffGEN study and coordinates the different sites for the study.
Will be responsible for the conduct and management of the study and reports to the Research Manager and Principal Investigator in this regard.
Work with lead site, site PI and UTSW to customize recruiting and follow-up process.
Build REDCap database(s), instruments and reports to record appropriate screening data for the site based on UTSW regulations and the information the lead site requires.
Reconcile data error checks reported by study data analysts, checking against source documentation.
Maintain records related to the conduct of clinical research - this includes copying/scanning forms, filing & electronically uploading study-related documents, and recording data directly into REDCap.
Establish & maintain a system for filing paper records for all study participants.
Copy/scan & upload study-related documents as needed.
Create informational materials related to research study for dissemination to study participants, researchers, and community.
Primarily working with genetics study of rotator cuff tears, provide support for other studies within research lab.
Develops Quality Management Program for clinical research program to achieve accreditation.
Ensures regulatory compliance of clinical research program.
Develops training program and system for onboarding study personnel at each participating site.
Develops and maintains website for marketing clinical research program.
Develops system using REDCap for data collection and management of clinical research program registry information. Coordinates development of clinical research program laboratory.
Coordinates interface between clinical research program and basic/clinical research collaborators at university and other institutions.
Provides general scientific support for clinical research program staff and university business office. Assists in developing and implementing research studies to include writing clinical trials.
Duties performed may include one or more of the following core functions:
Directly interacting with or caring for patients.
Directly interacting with or caring for human-subjects research participants.
Regularly maintaining, modifying, releasing or similarly affecting patient records (including patient financial records); or
Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records.
Attend weekly study team meetings and report to project manager about progress of trial.
Managing other research study coordinators for the study
**Other Duties: Performs other duties as assigned.
Supervision Received This position reports directly to a Clinical Research Coordinator Manager
Bachelor's degree in health science or an equivalent combination of related education and experience.
Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent and must be achieved by 01/01/24. After 01/01/24, certification is required within six months of date of hire.
Minimum 2 years of directly related experience in clinical research and clinical trials.
Associate's 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.
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.
4+ years of direct related experience.
Monday - Friday, with variability depending on the needs of study participants.
This position may be under-filled at the Clinical Research Technician title based on the selected candidate's qualifications.
This is a term-limited position with funding available through August 31, 2026, with an extension possible.
The Department of Physical Medicine and Rehabilitation in 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.
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.
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.
The University of Michigan is an equal opportunity/affirmative action employer.
A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.