Responsibilities*
Characteristic Duties and Responsibilities:
Expert level knowledge, skills, and abilities within 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
The Clinical Research Coordinator supports clinical research within the Division of Pediatric Nephrology and is expected to understand and support the conduct of research within all federal, state and local regulatory requirements. Candidate will perform independent work under the guidance of the program director and supervisor, while also collaborating as necessary to support overall program success. This coordinator is expected to participate in patient recruitment, consenting, and follow up activities in addition to underlying study coordination tasks.
Routine duties include:
- Support clinical research in Pediatric Nephrology to ensure clinical research related procedures are completed in accordance with good clinical practice guidelines.
- Collaborate within research team of physicians, biostatisticians, program/project managers, study coordinators, data managers, and administrative support.
- Screen, recruit, obtain consent, and retain participants according to research protocols.
- Coordinate pediatric/caregiver and adult patient follow up visits with research and clinical teams.
- Act as the primary point of contact for research participants, working with labs to handle biospecimens and pharmacies to place orders and pick up study drugs for research participants.
- Participate in communication of study results to participants when indicated.
- Serve as liaison between the clinical and research teams.
- Prepare and maintain Institutional Review Board (IRB) applications, consent documents, and recruitment materials for standard and/or ceding applications.
- Perform data collection, data entry, and query management.
- Collect, process, label and store biospecimens including blood, urine, and kidney biopsy tissue.
- Assist research administrative work such as data use agreements, material transfer agreements, and proposal submissions.
- Work with administrative staff to ensure appropriate billing for study-related care.
- Assist the research team in generation of presentations, abstracts, and manuscripts.
- 40% work from home (locally).
Required Qualifications*
- Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary.
- 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) and must be achieved by 01/01/24. After 01/01/24, certification is required within six months of date of hire.
- Minimum 3 years of directly related experience in clinical research and clinical trials is necessary
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/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.