- Coordinate day-to-day clinical trial operations in a remote capacity, ensuring compliance with study protocols and regulatory guidelines.
- Support and facilitate remote patient visits, including scheduling, documentation, and follow-up.
- Patient Recruitment support to include inclusion/exclusion understanding and qualifying patients for studies via phone.
- Maintain accurate and timely data entry in EDC and CTMS systems; manage query resolution.
- Assist with regulatory document management and remote IRB submissions and updates.
- Prepare for and participate in remote sponsor/CRO monitoring visits, audits, and inspections.
- Serve as a virtual liaison with sponsors, CROs, and internal site teams.
- Support study startup and closeout tasks, including remote collection and verification of essential documents.
- Monitor visit schedules and ensure all subject documentation is complete and up to date.
GCPData entry