Job Title: Clinical Research Associate (CRA) – Oncology
Location: Boston, MA (Hybrid or Remote, with travel)
Reports to: Director of Clinical Operations
Our client is a Boston-based biotechnology company dedicated to developing innovative oncology therapies that address unmet medical needs. The team is driven by scientific rigor, patient-centricity, and collaboration to advance cutting-edge cancer treatments from early development through late-stage clinical trials.
Position Summary
The Clinical Research Associate (CRA) will support the planning, execution, and monitoring of oncology clinical trials in compliance with ICH-GCP, FDA regulations, and company SOPs. The CRA will serve as a key liaison between investigative sites and the clinical operations team, ensuring data integrity, patient safety, and operational excellence across assigned studies.
Key Responsibilities
- Conduct site qualification, initiation, monitoring, and close-out visits for oncology clinical trials
- Ensure protocol compliance, data accuracy, informed consent integrity, and patient safety
- Monitor AE/SAE reporting, protocol deviations, and essential documentation
- Train and support site staff and maintain strong site relationships
- Review and maintain study documentation and Trial Master File (TMF)
- Track site performance, identify risks, and proactively resolve issues
- Collaborate cross-functionally and provide timely monitoring reports
- Support audit and inspection readiness
Qualifications
- Bachelor’s degree/Master’s degree in Life Sciences, Nursing, or a related field (required)
- 2+ years of CRA experience in clinical research (oncology preferred)
- Experience monitoring interventional clinical trials (Phase I–III preferred)
- Knowledge of Good Clinical Practices (GCP), clinical monitoring, study site oversight and management.
- Strong knowledge of ICH-GCP and FDA regulations
- Excellent communication, organizational, and problem-solving skills
- Ability to manage multiple sites and travel up to 30%
Offer
- Salary 100-150k (depending on level of experience)
- Career development opportunities in a growing oncology-focused organization
- Collaborative, mission-driven work environment in the Boston biotech hub