The Department of Otolaryngology—Head and Neck Surgery seeks a qualified candidate to serve as coordinator for the investigator-initiated, pediatric tracheal splint study (80% effort). This position will also devote 20% effort to clinical research projects in the University of Michigan C.S. Mott Children’s Hospital Congenital Heart Center. Responsibilities 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 and the Senior Project Manager.
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. 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 device procurement, and the collection and processing of research data and samples.
Will work closely with study 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 Clinical Trial Support Unit (CTSU) 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 OnCore system.
Work closely with the various faculty and staff within Michigan Medicine, 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, MICHR, CTSU other internal oversight groups and FDA for INDs and IDEs with sponsor and investigators.
Act as liaison between patients, research subjects, investigators, other departments, sponsors, and regulatory agencies.
Other duties as assigned.
?Requires bachelor’s degree in a science or health-related field
Experience in coordinating clinical studies
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
Meticulous attention to detail, 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
Excellent attendance record
Requires flexibility in work schedule
- ?Extensive experience with successful submissions to IRB
- Bachelor’s degree in Biomedical Engineering preferred
- Previous experience with coordination and management of medical device trials, including submission of an IDE Demonstrated understanding of FDA regulations
- Certification or planned certification through ACRP or SOCRA
- Experience with the University of Michigan’s eResearch system
- Experience with EPIC (Mi-Chart) electronic data system
- Reasonable knowledge of University research policies, procedures and computer systems
- Experience with multi-center clinical trials
This position reports to the Research Administrator for the Department of Otolaryngology—Head and Neck Surgery. Functional supervision is received on a daily basis from the Senior Project Manager. Additional functional supervision provided as needed by The Michigan Congenital Heart Outcomes Research and Discovery (M-CHORD) Program.
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. 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.