Job Description

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

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