We are seeking an experienced Freelance Clinical Research Associate (CRA) to join our dynamic team. The CRA will support the management and execution of clinical trials in Oncology, Hematology, and Rare Disease indications. This role is ideal for a motivated, detail-oriented professional with a strong background in clinical trial monitoring and a passion for advancing complex therapeutic areas.
This is a contract-based role, requiring flexibility for travel to clinical sites across the East Coast and occasional remote collaboration with cross-functional team
s.
Key Responsibilities
- Site Management & Monitoring:
- Conduct qualification, initiation, interim monitoring, and close-out visits to ensure compliance with study protocols, ICH-GCP, and regulatory requirements.
- Build and maintain strong relationships with site staff to ensure timely recruitment, data collection, and adherence to study timelines.
- Regulatory Compliance:
- Verify the accuracy and completeness of trial data and ensure proper documentation in accordance with ICH-GCP, SOPs, and FDA regulations.
- Support sites in resolving regulatory queries, protocol deviations, and monitoring findings promptly.
- Data Integrity:
- Perform source data verification (SDV) to ensure clinical data accuracy and completeness.
- Monitor and resolve data discrepancies in collaboration with the data management team.
- Study Oversight:
- Provide guidance and training to site personnel on protocol requirements and study-specific procedures.
- Collaborate with study teams to support safety reporting and ensure proper handling of adverse events (AEs) and serious adverse events (SAEs).
- Communication:
- Prepare monitoring reports and maintain regular communication with the Project Manager and cross-functional teams.
- Escalate issues that may impact study timelines or quality to the appropriate stakeholders.