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Clinical Research Project Manager, College Of Medicine, Department Of Neurology & Rehabilitatio[...]

Itlearn360

Job Overview We are seeking a full‑time Clinical Research Project Manager for the Department of Neurology & Rehabilitation Medicine at the University of Cincinnati College of Medicine, Cincinnati, OH. The role will oversee a PCORI‑funded study, TESTED, evaluating endovascular clot retrieval versus medical management for acute ischemic stroke patients with pre‑existing disability across approximately 44 U.S. and Canadian sites. Essential Functions Serve as the primary regulatory point of contact for the single Institutional Review Board (IRB) at the University of Cincinnati and performance sites, managing site activation and closure processes. Coordinate site startup activities and provide regulatory assistance for the single IRB process, including submitting and tracking central and site‑level IRB submissions, translated informed consent documents, PI changes, and other modifications. Ensure IRB compliance across all sites by reviewing site, regulatory, and staff documents, managing the financial interest disclosure process, overseeing the delegation of authority log process, assisting with REDCap eConsent management, and facilitating IRB approvals for site Principal Investigator changes. Track and assist with the clinical trial agreement process, oversee safety surveillance throughout the study, report unanticipated problems, non‑compliance, and serious protocol deviations to the IRB and Data Coordinating Center, and drive the CAPA process. Perform additional duties as required by the department. Required Education Bachelor’s Degree. Nine (9) years of relevant work experience and/or other specialized training may be used in lieu of the degree requirement. Required Experience Five (5) years of related experience in clinical trial or large observational study coordination and regulatory oversight. Additional Qualifications Considered Experience in an academic or clinical setting in a clinical specialization. SoCRA or ACRP certification. Physical Requirements/Work Environment Sitting continuously. Compensation and Benefits Competitive salary commensurate with experience. Comprehensive health coverage (medical, dental, vision, prescription). Flexible spending accounts & wellness programs. Professional development & mentorship opportunities. Tuition remission for employee and eligible dependents. Retirement plans: state pension, Alternative Retirement Plan. Paid time off: vacation, sick time, 11 paid holidays, end‑of‑year paid time off, 6 weeks parental leave. Equal Opportunity Employer The University of Cincinnati is an E‑Verify employer and requires satisfactory proof of employment eligibility via the Federal I‑9 process. We provide accommodations for applicants with disabilities. We are committed to equal opportunity employment for all qualified applicants, including individuals with disabilities and protected veterans. #J-18808-Ljbffr Itlearn360

Vacancy posted 4 days ago
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