Clinical Research Associate
Company: High5 Agency
- Location: Tampa, United States
- Seniority: Senior
- Employment type: Full-time
- Posted: 13 days ago
- Offer language: English
Job description
Key Responsibilities
- Conduct all phases of site monitoring activities, including site selection, initiation, routine monitoring, and close-out visits.
- Evaluate site performance and ensure adherence to study protocols, GCP, ICH guidelines, and applicable regulatory requirements.
- Partner with investigative sites to develop, implement, and track patient recruitment and retention strategies that support enrollment goals.
- Deliver protocol-specific training and maintain ongoing communication with site staff to ensure alignment on study expectations and timelines.
- Identify, document, and escalate quality or compliance concerns while supporting timely resolution of issues.
- Monitor study progress by tracking regulatory submissions, approvals, enrollment metrics, CRF completion, and data query resolution.
- Ensure essential study documentation is complete, accurate, and maintained within the Trial Master File (TMF) and Investigator Site File (ISF).
- Prepare comprehensive monitoring reports, follow-up letters, and other required study documentation in accordance with company and sponsor standards.
- Collaborate cross-functionally with project teams to support study execution and achievement of project milestones.
- May participate in study start-up activities, site budget tracking, financial management, and site payment processes, depending on assignment.
