- Keep site, vendor, and internal study team contact details current and accurate.
- Aid in initiating clinical trials, including feasibility assessments, investigator recruitment, regulatory document collection, and general site management.
- Engage directly with sites to ensure the collection of essential documents from start-up through study completion.
- Collaborate with the study team to identify study risks and develop mitigation plans, involving management communication when necessary.
- Analyze monitoring reports and visit letters to evaluate trends and site performance.
- Create and maintain documents and plans for clinical studies, including training materials, operating manuals, presentations, and reports.
- Assist the study team in developing and implementing tools to ensure clean and timely data entry, and support clinical data review and query resolution as needed.
- Participate in and manage meetings with the study team, CROs, vendors, and multi-functional teams, including preparing agendas, minutes, and tracking action items.
- Oversee the performance of field CRAs, including co-monitoring to ensure protocol compliance and adherence to scope of work, and escalate concerns to study leads or Clinical Operations Management.
- Assist in training CRAs and third-party vendors on protocols and practices.
- Maintain study tracking systems, including regulatory Q&A, site start-up timelines, protocol issue trackers, and other relevant tracking.
- Work with the CRO and study leads to keep the Trial Master File inspection-ready.
- Conduct and support quality control reviews of study files, including resolving issues.
- Potentially conduct Pre-Study Visits and Site Initiation Visits.
- Support submissions and approvals from local Health Authorities and Ethics Committees.
- Assist with the inventory, tracking, shipping, and reconciliation of Investigational Products at clinical sites.
- Aid in negotiating and managing site budgets and reviewing clinical site invoices, in collaboration with study leads or the VP of Clinical Operations.
- Monitor and report on study progress, including site activation, patient enrollment, and monitoring visits.
- Lead or participate in assigned functional initiatives and activities.
EOE Statement : Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
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