- Manage 2–3 clinical trials including study start-up, site monitoring, and closeout.
- Conduct on-site and remote monitoring visits and complete monitoring visit reports.
- Perform source data verification (SDV) and ensure quality and completeness of Case Report Forms (CRFs).
- Train site staff in study procedures and manage investigational products and trial materials.
- Support safety reporting, including AEs, SAEs, and SUSARs, ensuring timely follow-up.
- Act as the primary contact for study sites to ensure proper execution of protocols.
- Conduct study termination and archiving activities.
- Mentor and supervise Clinical Research Associate I (CRA I) staff.
- Assist with study site feasibility, budget negotiations, and submission processes.
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