Clinical Trial Manager II

We are looking for a Clinical Trial Manager II to join our team! Are you well organized and adaptable to unexpected changes? Someone who is able to see the bigger picture, without losing sight of the day-to-day tasks? If the answer is yes, keep reading! Clinical Trial Manager II serves as the primary point of contact for clinical trials site operations. In this position you will: Serve as the secondary contact to address site questions when the site Clinical Research Associate (CRA) or Research Assistant (RA) is unavailable. Ensure CPC SOPs, Good Clinical Practice guidelines and applicable federal, state and local regulations are being followed. Review monitoring visit reports and follow-up letters for Site Endpoint Evaluation Visits, Site Evaluation Visits, Site Initiation Visits, Routine Monitoring Visits, and Close-out Visits and Addendums and work with CRAs to clarify issues and finalize reports and follow-up letters. Review site specific Informed Consent Forms (ICFs) to address site specific changes and escalate to internal or external parties for approval, as needed. Provide the Project Manager with metrics and updates on sites including but not limited to: study related site enrollment, site activations, protocol deviations, monitoring reports and follow-up letters status. Assure proper maintenance of site required records for monitoring activities and required regulatory documents per CPC requirements. Create and/or review study-specific monitoring visit reports and,