The Michigan Center for Translational Pathology (MCTP) is seeking a Clinical Research Coordinator. This position will also work with faculty in the Department of Hematology/Oncology.
Serve as Clinical Research Project Manager to the group in the areas of group research activities and special projects. Assist with all aspects of research administration throughout the life of a study; independently analyze, compare and evaluate various courses of action with relation to research administration activities and work in a collaborative manner with a multidisciplinary team of faculty, nurses, technicians, coordinators, and administrators.
This position is responsible for management of multiple complex industry sponsored, multi-center, research trials as well as investigator initiated clinical trials in accordance with Good Clinical Practices (GCP) guidelines and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), FDA, and other relevant local and government regulations.
This position is responsible for the regulatory aspects of multiple sponsored research trials including all IRB requirements, training records, corrective and preventative actions, and development of standard operating procedures.
- Write, edit, and renew IRB applications including all informed consent documents, patient materials, marketing materials, and other related documents. Ability to work in multiple systems including eResearch as well as commercial IRB systems.
- Work with CRAO and the Billing Office to make sure research biopsies are charged correctly.
- IdentOn fy, track, document, and submit reports of all serious adverse events, adverse events and protocol deviations according to FDA regulations, approved protocols, and IRBMED guidance. Report and analyze information to ensure corrective and preventative action is completed.
- Assure compliance with protocols, adherence to good clinical practice guidelines, FDA regulations, and all other federal, local, and University guidelines through a quality assurance program.
- Write, prepare, edit, and review clinical trial protocols. Prepare research reports and manuscripts for publication and presentation at conferences and workshops. Write, edit and/or approve progress and technical reports.
- Enter clinical data for study patients into CAISIS database at collaborating institution, resolving missing data issues as needed for collaborative clinical projects.
- General project administration.
Bachelor’s degree and at least 2 years full time clinical research experience. Demonstration of excellent organizational and problem solving skills.
Monday - Friday, 8:00am - 5:00pm
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.
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The University of Michigan is an equal opportunity/affirmative action employer.