Clinical Trial Coordination & Execution
Manage all phases of clinical trials from initiation to close-out. Conduct study visits, obtain informed consent, perform protocol procedures, and enter data accurately into eCRFs using eSource systems.
Technology & Compliance
Utilize clinical trial platforms (eSource, eConsent, eISF) to maintain regulatory-compliant documentation. Ensure site adherence to 21 CFR Part 11, ICH GCP, and sponsor SOPs.
Regulatory & Audit Readiness
Maintain regulatory documentation and assist in audit preparation for sponsors, CROs, and regulatory agencies.
Patient Engagement & Safety
Recruit, screen, and enroll participants per protocol; monitor and report adverse events to ensure patient safety.
Collaboration & Site Support
Act as liaison with sponsors, CROs, and monitors. Mentor new CRCs and provide on-site support or travel as needed for multi-site coordination, audits, or meetings.
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