The University of Michigan Congenital Heart Center is seeking a highly motivated individual to serve as a Clinical Research Coordinator for the Michigan Congenital Heart Outcomes Research and Discovery (MCHORD) Program.
- To serve as coordinator for both single and multi-center, investigator initiated and industry sponsored, clinical studies, with responsibilities to include participant recruitment and retention efforts, medical record data extraction, data entry, and management of IRB and other regulatory matters related to clinical research under the instruction and direction of investigators.
- The selected candidate will work with investigators, other research coordinators, database managers, and a biostatistician as part of a congenital heart center clinical research team.
- Prepare, maintain and manage IRB (eResearch) applications including new applications, scheduled continuing reviews, amendments, adverse event reporting (events that either occurs in UM research subjects or subjects from other centers in multi-site studies) and other reportable information and occurrences.
- Accurately collect, maintain, complete electronic and paper case report forms and manage patient and laboratory data for clinical research projects, related to single center and multi-center studies. Appropriately maintain research study regulatory binders and subject binders ensuring the data is maintained per research protocol and in a secure environment.
- Will provide oversight and screen for the recruitment of research subjects, supervise scheduling of appointments, and the collection and processing of research data and samples.
- Will work closely with industry sponsors’ monitors including managing site visits. This includes study initiation visit, monitoring visits, and the study close out visit. Report adverse events, subject enrollment, protocol deviations and research subject data to sponsor per protocol. Manage the return of research study materials to sponsor.
- Will work with division finance staff to assure tracking of patient visits matches finances. Process and maintain research subject payments through the HSIP program. Create, maintain and manage Clinical Research Billing Calendars and subject enrollment through the MBECT system.
- Work closely with the various faculty and staff within UMHS system, balancing the needs of each and completing the desired work in a timely fashion.
- Assure compliance with protocols, good clinical practice guidelines and FDA regulations with potential to serve as liaison to the IRB, other internal oversight groups and FDA for INDs and IDEs with sponsors and investigators.
- Act as liaison between patients, research subjects, investigators, other departments, sponsors, and regulatory agencies.
- Requires Bachelor degree in a science or health-related field or equivalent education and experience.
- Experience in coordinating clinical studies
- Certification or planned certification through ACRP or SOCRA
- Demonstrated knowledge of medical and research terminology. Ability to work with minimal supervision with diverse teams of people in a diplomatic, collaborative and effective manner
- Excellent interpersonal, oral, and written communication skills
- Exceptional organizational and computer skills are required with proficiency in Microsoft software applications
- Demonstrated problem solving and conflict resolution skills. Ability to multi-task, work well under time constraints and meet deadlines
- Extensive experience with successful submissions to IRB
- Familiarity with congenital heart disease
- Previous experience with coordination and management of device trials (IDE and HDE)
- Demonstrated understanding of FDA regulations
This position reports to the MCHORD program directors. Functional supervision is received on a daily basis from the principal investigators, co-investigators, and project leads. Administrative Supervision is received from the MCHORD Faculty and the Administrative Manager.
Functional supervision is exercised for work-study students and other temporary employees/volunteers.
University of Michigan Health System 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.
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.