How to Apply
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 Clinical Subjects Coordinator will be responsible for collecting and managing patient data for industry-sponsored and investigator initiated clinical studies involving Inflammatory Bowel Disease. Principal duties will include: Patient recruitment, including 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, making sure that they both understand and are capable of adhering to study requirements. Schedule and oversee subject visits, which involve the administration of surveys in person or by telephone, obtaining of medical histories, and collection of biological specimens. Responsibility for the management of all subject records and documentation and the maintenance of a Microsoft Access or REDCap secure database created to house this information. Monitoring subjects for safety and compliance with protocols and for the analysis of patient data. Effectively communicate with the IRB for clinical study approvals, amendments, and continuations. Effectively update granting agencies on annual progress of research projects. Supporting a busy clinical research program. Coordinate multiple clinical studies - budget preparation, IRB application and reporting of adverse events, review medical records, recruit patients, screen patients for eligibility, follow patients in the study, monitor side effects, review test results, enter data into case record forms (hard copy and electronic), reconcile study expenses, communicate and negotiate with study sponsor, IRB, investigational pharmacy, patients, referring doctors, Michigan Clinical Research Unit (MCRU) team and UM Clinical Trials Office.
College degree, with nursing (preferred) / health sciences training or training in clinical research is necessary. Minimum of two years’ experience in clinical research including recruitment, IRB applications, and/or budget preparation is necessary. 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. Experience with databases, including Microsoft Access, as well as, experience within the University of Michigan clinical trials system is highly desirable.
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.
The University of Michigan Health System 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.