Responsibilities*

Assist Oncology Clinical Trials Support Unit (OCTSU) manager and serve as a resource for portfolio managers in providing study coordinator data support; apply OCTSU policy, and IRB, FDA, ICH, GCP and HIPAA regulations; provide study coordination support for investigator-initiated and commercially sponsored trials; collect and record data; work closely with staff and biostatistician core to ensure compliance and assist in data analysis; register patients to trials; abstract data on patients from various sources; participate/organize site visits; attend investigator meetings for pharmaceutical studies; act as liaison with regulatory team, study team, and federal and industrial sponsors; prepare for and participate in monitoring visits; provide project management and data management support to all OCTSU data management team; utilize RETA, CERVANT, Workload scores, and study activity to provide input on areas of need; coordinate study transition and project-specific training; attend team and program meetings to reinforce OCTSU roles, policies, and procedures; assist with addressing both high-level process issues that affect the conduct of trials and issues raised by programs and clinical staff; assist with developing processes and promoting standardization; participate in leadership initiatives and work with managers in drafting and developing policy; and manage entry study coordinators, including hiring, training, assigning work, and performance management. Supervision of 1-3 entry-level study coordinators.

Required Qualifications*

• Requires Master's degree in Clinical Research Administration
• +2 years of academic clinical research administration experience in oncology: conducting data management using clinical research databases WCG e-Research, Medidata RAVE, and Epic EMR; assisting with clinical trials from site initiation visit to conducting and closing the trial; preparing for internal and external audits; implementing corrective and preventative action plan(s).

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.

Vaccine Requirements

COVID-19 vaccinations are required for all students, faculty and staff working in the following areas: Michigan Medicine including the Medical School, Dental School, University Health Service or the Mary A. Rackham Institute. This includes those working remotely and temporary workers. More information on this new policy is available on the U-M Health Response.

U-M EEO/AA Statement

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