Principalresponsibilitiesinclude the following:
- Participate in Site/Investigator selection process by providing recommendations from local area.
- Assess site experience, facility, and Electronic Data Capture (EDC) capabilities to perform study activities.
- Execute activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/Work Instructions (WIs)/Instructions for Use (IFUs) and policies.
- Ensure Visit Reports are written and submitted via electronic Trial Master File (eTMF) within 5 working days.
- Ensure site staff resolve data queries, and works with sites to ensure data timelines are met.
- Maintain accurate and timely data in systems utilized for clinical trial management and update site payments in Clinical Trial Management System (CTMS).
- Ensure, in collaboration with LTM, the timely and accurate data collection, documentation and communication of site/study progress and issues.
- Plan, conduct and document site staff training and monitor site performance.
- Update training matrix in SharePoint as necessary and ensure all site personnel training documentation is on file at the site and in the Investigator File.
- Contribute to site level recruitment strategy and contingency plan in partnership with other functional areas to achieve clinical research targets.
- Present/participate in Investigator Meetings as needed and monitor expiry date of Investigational Product and ensure study supply strategy is adequate.
- Work with LTM to ensure Corrective Action/Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits.
- Mentor new hires with supervision and serve as Lead Site Manager (SM)/SM EDC Specialist for a specific trial as needed.
- In conjunction with LTM, review electronic Case Reports Forms (eCRFs) and Completion Guidelines and participate in EDC User Acceptance Testing (UAT) testing and special initiatives as needed.
- A minimum of an Associate’s degree or completion of a Nursing Program (RN) is required. A Bachelor’s degree in a Health or Science discipline is preferred.
- A minimum of 4 years of clinical monitoring experience is required.
- Clinical research monitoring experience in Oncology is required.
- Experience with Phase II and Phase III Clinical Trials required.
- Strong knowledge of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations, is required.
- Experience working with computer software applications is required.
- Must have strong written and oral communication skills.
- Willingness to travel 50%, approximately 2-3 days per week, with overnight stays (1-2 nights on average), is required.
- A valid Driver's License issued in one of the 50 United States and a good driving record is required.
Requisition ID: 4401170309