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Description The Cancer Institute Clinical Research Unit at West Virginia University Research Corporation is currently accepting applications for a (Hybrid) Regulatory Coordinator About the Opportunity The Protocol Management Office (PMO) as a unit within the WVU Cancer Institute Clinical Research Unit (WVUCI CRU) is tasked with general regulatory and financial oversight of all active WCUCI clinical research studies from open to accrual through termination. Under the direction of the Protocol Management Manager, the Regulatory Coordinator position is responsible for completing all regulatory activities associated with active industry and cooperative group sponsored clinical studies. The Regulatory Coordinator is also tasked with the start-up of cooperative group sponsored clinical studies. At WVU Research Corporation, we strongly believe in work-life balance and keeping time for things we love outside our work. WVU Research Corporation offers a comprehensive benefits package with a variety of options to suit your needs: 13 paid holidays (staff holiday calendar) Paid Time off (PTO) 403(b) retirement savings with a fully vested 3% employee contribution match, (Employees have the option of contributing an additional 1-3% of their earnings to the plan, which is also matched by the WVURC) A range of health insurance and other benefits Dependent Education Scholarship WVU Perks What You'll Do Cooperative Group Protocol Start-up Activities: The Regulatory Coordinator is responsible for the study start-up activities for cooperative group sponsored protocols. Facilitates new protocol submission for disease team and protocol review committee reviews and notifies relevant research staff of approvals Prepares and submits new and annual Principal Investigator Worksheets for the NCI CIRB Submits Study Specific Worksheets for new protocol to the NCI CIRB and prepares informed consent forms in accordance with Institutional Submits new protocols to the WVU IRB for local review and acknowledgement Schedules and assists in making materials for site initiation visits Creates initial delegation and training logs Protocol Maintenance Activities: The Regulatory Coordinator is responsible for the lifetime management of all WVUCI industry-sponsored, and cooperative-group sponsored protocols. Prepares and submits IRB continuing reviews and amendment review Updates protocol specific regulatory documents including FDA Form 1572, Financial Disclosure Forms, Delegation Logs, and Training Logs as neede Reviews all protocol specific deviations, safety reports, and adverse event reports for reportability, and submits to the IRB when applicabl Responds to questions regarding regulatory issues, including queries from internal quality review and the Data Safety and Toxicity Committe Participates in WVUCI disease team-oriented research meetings, to also include research affiliate network, with investigators and coordinators to ensure prompt and accurate communication of changes in the protocol plan, IRB comments and other regulatory item Prepares for study monitoring and auditing visits by reviewing all protocol specific regulatory files and reconciling as needed. Notifies appropriate institutional officials of external audits by FDA and sponsor Maintains professional and prompt communications with investigators, coordinators, and sponsors as required Protocol Closeout Activities: The Regulatory Coordinator is also... For full info follow application link.

West Virginia University Research Corporation is proud to be an Equal Opportunity employer. West Virginia University Research Corporation values diversity among its employees and invites applications from all qualified applicants regardless of race, ethnicity, color, religion, gender identity, sexual orientation, age, nationality, genetics, disability, or Veteran status.