The Division of Pulmonary and Critical Care Medicine is currently seeking a well-qualified clinical research coordinator. The selected candidate will perform clinical research within Critical Care Medical Unit in partnership with the Emergency Department at the University of Michigan Medical Center.
Study coordinator will work in a collegial fashion with principal investigators, project manager, study coordinators, research administrators, and the CTSUs. Duties include but are not limited to:
- Coordinates and executes designated clinical trials, including screening and enrolling patients; carrying out subject study visits; data entry; and follow up with subject and study physician regarding any health concerns of the patient.
- Coordinates recruitment of patients for all assigned clinical trials. Receive cross-training on trials within the Acute, Critical Care, Surgery, and Transplant Clinical Trial Support Unit in order to provide coverage for screening and enrollment into these trials on assigned weekends.
- Prepare comprehensive reports in the form of source documents, notes to file, etc., on each research patient, along with maintaining and completing the supplied case report forms; prepare project reports as required by PI, sponsor and/or project manager.
- Manage all patient research data for assigned clinical trials; including data entry and preparing appropriate reports for sponsors and/or principal investigators.
- Responsible for managing the regulatory aspects of assigned trials, including amendments, ORIOs, adverse event reporting, serious adverse event reporting.
- Participate in conferences and investigator meetings related to the assigned clinical trials in order to learn of new developments or the progress of the trial.
- Act as a liaison between patient, investigators, project manager, other departments, sponsors, vendors, and regulatory agencies.
- Process and store biological samples (blood) from patients in a safe and consistent manner (training will be provided).
- Bachelor's degree in a health science discipline required.
- Previous experience with the coordination and management of clinical trials is required.
- Ideal candidate will have knowledge of good clinical practice, responsible conduct of research, HIPAA and PEERS certification (or willingness to become certified) and experience with IRBMed submissions.
- Outstanding organization skills and attention to details and deadlines required.
- Must be able to work independently and have excellent interpersonal skills to interact with investigators, attending physicians, ICU nursing staff, patients and their family members.
- Previous experience with eResearch Regulatory Management system preferred.
- Experience with IRB policies and procedures preferred.
- Any previous experience with ICU patients or inpatient clinical research is highly desirable.
- Master's degree preferred.
Shift/Hours/Days: Days / 8:00 a.m. to 5:00 p.m. / M-F
40 hours, full time. Some weekend and night coverage will be required, must be able to accommodate a flexible schedule as necessary in inpatient research.
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.
Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.
Job openings are posted for a minimum of seven calendar days. This job 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.