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.
Job Summary
This position will serve as a Technical Allied Health Misc. in the Oncology Clinical Trial Support Unit (O-CTSU) providing administrative study coordination, regulatory, and/or data entry support to faculty and research teams for the University of Michigan Rogel Cancer Center - an NCI-Designated Comprehensive Cancer Center and a member of the National Comprehensive Cancer Network (NCCN). We are among the top-ranked national programs in research and patient care with members holding $120M in annual direct research funding. Our mission is to reduce the cancer burden and improve cancer outcomes through research, innovation and transdisciplinary collaboration. With the Oncology CTSU, you will join a diverse team of 150 clinical research professionals dedicated in moving this mission forward through cutting-edge early phase trials to practice-changing phase III. As a team member, we will invest in your education, training, career development and certification. We also offer a variety of specialized roles and growth opportunities to fit your desired career path and goals. People want MichiganAnswers?. Help discover them.
Responsibilities*
- Provide regulatory study coordination for clinical research trials (investigator initiated and commercially sponsored trials).
- Collect regulatory documents in timely fashion and enter into site trial master file.
- Prepare amendment documents, renewal documents, and reports for IRB submission.
- Participate in Site Visits (UofM).
- Ensure compliance with GCP, FDA regulations, ICH regulations, and IRB policies and procedures.
- Provide administrative support for clinical research tasks.
- Provide research support to team.
- Management of the Study (maintain up to date protocol specific documentation, etc.).
- Prepare for Audits - internal (QARC) and external (FDA, Industry).
- Data Safety Monitoring preparations for PRC Executive Committee Sponsors, Cooperative Groups, FDA.
- Prepare for and participate in Monitoring Visits.
- Assist in special projects.
- Prepare/Attend study closeout meetings.
Required Qualifications*
- Bachelor's degree in Science or a Health Science related field.
- Minimum 1 year experience in regulatory management.
- Direct clinical research experience, or equivalent work experience.
- To be successful in this position the candidate should have a working knowledge of GCP and FDA regulations governing clinical research.
- Candidate must possess IT proficiency, IRB submission experience, familiarity with medical terminology, excellent written and oral communication skills and self-motivation.
- Candidate must demonstrate the ability to thrive in a dynamic, fast paced team environment but must also be able to work independently under limited supervision.
- The candidate must possess interpersonal skills with exceptional attention to detail and the willingness to contribute in a team setting.
- Exceptional organizational skills required.
- Previous research/data management experience required.
Modes of Work
Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.
Background Screening
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.
Application Deadline
Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.
U-M EEO Statement
The University of Michigan is an equal employment opportunity employer.