The Department of Radiation Oncology is seeking a project manager to work with research faculty and research teams conducting clinical trials within various disease sites at the Ann Arbor VA Healthcare System.
This Project Management position is responsible for the coordination and maintenance of all Clinical Research Protocols at the Ann Arbor VA Hospital in the Department of Radiation Oncology. 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 Support Unit, and the University of Michigan NCTN group for National Clinical Trials Network.
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 all aspects of clinical research (regulatory work, data management, and clinic coordination).
The ability to work independently is a must. The ideal candidate will also work effectively on a team with excellent interpersonal skills and communication. 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 will be under the direction of the Radiation Oncology Clinical Trials Manager
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Michigan Medicine 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. 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.
Internal Number: 190246
About University of Michigan - Ann Arbor
A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.