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.

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.

• Provide data management and study coordination for clinical research trials (investigator initiated and commercially sponsored trials).
• Collect quality data in timely fashion recording data on case report forms and entering into database.
• Register patients to trial in Clinical Trials Database/with Sponsor after confirmation of eligibility.
• Abstract data on patients from various sources.
• Participate/Organize 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 in the clinical setting.
• Management of the Study (maintain up to date protocol specific CRFs, etc.).
• Obtain source documents for CRF completion.
• 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 Regulatory Document Maintenance and special projects.
• Schedule/Prepare/Attend study closeout meetings.
• Data Entry.
• Specimen handling and shipping.

• Bachelor's degree in Science or a Health Science related field.
• Minimum 1 year experience in data 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, database 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.

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.

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.  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.

The University of Michigan is an equal opportunity/affirmative action employer.