Oversight for clinical projects and responsibility for ensuring that they are completed within specifications by defining operational objectives and assignments, managing project resource needs within specified timelines and budget, and reporting test results. Manage all patient research data; prepare appropriate reports for investigators and/or sponsors, including maintaining and completing the supplied case report forms; project reports as required by sponsor; and coordination and participation in site visits with the sponsor. Manage and coordinate data related to patient participation in studies and work flow as needed by multiple studies. Participate in conferences related to the project and/or progress. Act as liaison between patients, investigators, nurses, other departments, sponsors, vendors, and regulatory agencies. Coordinate recruitment of patients for heart failure trials and patient education relative to study participation. Participation in the development of general goals for the research project and in the planning of the field work; plan and coordinate work of graduate students and other support personnel; and serve as a consultant to the project director, faculty, and staff. Review proposed investigator-initiated clinical research protocols and ongoing review of active protocols (including review of safety data and through discussions with local site coordinators) to identify areas of potential or demonstrated risk to patients in the conduct of the protocol and development of solutions.
Medical Degree or foreign equivalent + 3 years' experience as clinical research coordinator (including at least one year in cardiovascular disease) to include conducting and monitoring randomized clinical trials and observational registries + Certified Clinical Research Professional (CCRP) certification.
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U-M EEO/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.