Clinical Research Coordinator (Oncology)

Responsibilities*

Clinical Research Coordinator in the Oncology Clinical Trial Support Unit (O-CTSU) specializing in data management and regulatory coordination work. Contributes to the development of processes and tools to support the non-GCP and GCP-related activities associated with study execution. Performs study procedures with accuracy. Conducts all startup, active implementation, and closeout activities. Independently coordinates teams' most complex trials with little to no oversight. Creates corrective and preventative action plans. Develops processes, tools, and training to capture data in accordance with ALCOA-C principles. Manages databases. Monitors site compliance with subject safety reporting, escalates issues, and contributes to the development of tools and processes to enhance subject safety. Contributes to process and tool development to enhance site compliance. Acts as a liaison between investigators, research teams, sponsors, other universities, cooperative groups, other internal and external departments. Runs study meetings. Reviews study forms, databases, and all study-related work for completion and accuracy. Develops standard operating procedures, work-aids and other guidance. Provides mentorship to clinical research staff. Up to 80% remote work permitted.

Required Qualifications*

Requires Bachelor's degree in Clinical Research Administration + 2 years of academic clinical research administration experience in oncology focused on therapeutic intent, which includes: managing investigator-initiated and industry study protocols; conducting data management using Velos CDMS, Rave EDC, and Epic EMR; assisting with clinical trial from site initiation visit to conducting and closing the trial; preparing for internal and external audits; and implementing corrective and preventative action plan(s). Candidates must be eligible to register for and take the ACRP or SOCRA certification exam at date of hire. 

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.

U-M EEO Statement

The University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.