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Coordinator, Clinical Operations

Company: Jenavalve
Location: Irvine
Posted on: January 16, 2020

Job Description:

Reports to the Associate Director of Clinical Operations and contributes to the delivery and completion of various departmental projects and goals. Assures compliance with regulatory and clinical guidelines. Responsible for maintaining Trial Master Files and trackers. Assists clinical monitors in preparation of site training and monitoring visits. Assures clinical trial conduct in accordance to all regulations (e.g. regulatory guidelines, national/international standards) Job Responsibilities: Maintain Trial Master Files (TMF) and trackers for clinical trials by overseeing and managing Electronic filing system/SharePoint(s) and hard copy files. Keep regulatory documents and monitoring tools updated and uploaded in both systems; assess all data documentation for completeness and accuracy, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements. Contact point for field monitors, in-house CRAs and trial management team in supporting clinical site training and monitoring visits. Providing monitoring report templates and updates on outstanding site action items and site-specific trackers for investigational site study documents. Manage trial-related regulatory documents and provide follow-up action listings to ensure that all clinical documentation required by regulations and JenaValve procedures are current. Conduct periodic audits of internal files to ensure compliance per site Institutional Review Board (IRB) and/or Ethics Committee (EC) policy (i.e. IRB continuing review approval period and expiration dates). Audit/review internal and external logs (i.e. device accountability, training, delegation of authority (DOA). Provide Clinical Operations support during preparation for and conduct of all clinical audits and inspections.

Keywords: Jenavalve, Irvine , Coordinator, Clinical Operations, Other , Irvine, California

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