The Department of Radiation Oncology is seeking a candidate to provide clinical research support to faculty members and research team members in the conduct of clinical trials within various disease sites at the Ann Arbor VA Healthcare System.
Primary responsibilities include instructing and counseling VA patients in research protocol background/significance and procedures; screening subjects for eligibility; scheduling protocol-related interdepartmental appointments, both at the AA VAHS and UMHS; collecting and processing clinical data; administering protocol specific research testing (i.e. neurobehavioral, Quality-of-Life questionnaires); managing research regulatory process; and working closely with investigators, study team members, regulatory personnel, and other health care professionals to help complete research goals and ensure compliance with VA, University and Federal Government Regulations.
Additional responsibilities include: maintaining appropriate patient records, generating required regulatory reports, compiling regulatory records, collecting source documentation for results, resolving data queries from oversight groups, facilitating specimen collection, data entry into electronic research database (VELOS), and monitoring patient study compliance, including continuing patient communication throughout the follow-up period. Candidate will be responsible for all VA regulatory submissions including new study applications, renewals, amendments, and reportable events. Must be able to work closely with VA IRB and Research & Development coordinators and reviewers. The candidate will also be responsible for organizing and providing documents for enrollments, monitoring and audits, as requested by the VA Compliance Officer, the University of Michigan Cancer Center Clinical Trials Office, and the University of Michigan NCTN group for National Clinical Trials Network.
This position will be under the direction of the Radiation Oncology Clinical Trials Manager.
This position requires the knowledge of a health-related discipline, supported by a Bachelor's degree or equivalent experience. This knowledge base requires supplementation by two or more years of experience in the conduct of clinical research. The ability to work effectively on a team and problem solve independently is a must. This is a dynamic work environment with an emphasis on clinic cooperation for the benefit of the patient. Therefore, the ideal candidate would enjoy developing patient and colleague relationships to improve study compliance and meet research goals. Excellent communication skills, attention to detail, and prioritization are vital. The candidate must demonstrate reliability, resourcefulness, and initiative.
Familiarity with oncology clinical trials, working knowledge of Federal regulations in the conduct of research involving human subjects, and working knowledge of DSMCs and regulatory audits are all highly desirable. Familiarity with VA system is also desirable.
This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.
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.