Research - Laboratory/Non-Laboratory, Staff/Administrative
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.
The Division of Gastroenterology is seeking a qualified candidate for the full-time position of Clinical Subjects Coordinator. The Clinical Subjects Coordinator will be responsible for managing both industry-sponsored and investigator-initiated clinical studies involving Inflammatory Bowel Disease.
Clinical Trial Subject Maintenance- Subject visits: scheduling visits, administering surveys in person or by telephone, obtaining of medical histories, collecting/processing biological specimens, entering data into electronic system, and responding to queries regarding study data. Subject records and documentation management. Monitoring subjects for safety and compliance with protocols. Analysis of patient data.
Patient Recruitment- Pre-screening patient medical records, calling or interviewing potential subjects face-to-face to confirm eligibility, and consenting for the above studies after exercising professional judgment on whether subjects meet inclusion and exclusion criteria.
Regulatory Management- Effectively communicate with the Institutional Review Board (IRB) for clinical study approvals, amendments, and continuations. Organize and maintain clinical trial regulatory documentation, training, and delegation.
Grant submission and maintenance- Effectively update granting agencies on annual progress of research projects.
Coordination and communication with others- Study team, Study sponsor, IRB, Investigational pharmacy, patients, referring providers, Michigan Clinical Research Unit (MCRU) team and Clinical Trial Support Unit (CTSU).
Bachelor’s degree in a life science or equivalent work experience is required. Employment experience with direct patient interaction is required (>1 year). Essential to be proficient in computer programs including word processing and spreadsheets. Must possess good communication skills. Must be organized, attentive to detail, motivated to learn, and capable of functioning independently.
Knowledge of regulatory requirements is desirable. Experience with databases, including Microsoft Access, as well as, experience within the University of Michigan clinical trials system is highly desirable. College degree, with health sciences training or training in clinical research is necessary. Previous experience in clinical research including recruitment, IRB applications, and/or budget preparation is necessary. Databank (including RedCap) experience is a plus. Statistics training is a plus. MPH graduates especially encouraged to apply.
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.
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.
The University of Michigan is an equal opportunity/affirmative action employer.
Internal Number: 169768
About University of Michigan - Ann Arbor
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.