Clinical Research Associate
Listed on 2026-02-14
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Research/Development
Clinical Research, Medical Science -
Healthcare
Clinical Research, Medical Science
Clinical Research Associate (CRA) – Phase I Oncology (Liquid Tumours)
Location: Boston, MA (hybrid) or Remote (East coast or Central)
Job Type: Full-Time
Travel: Approximately 50% across 10 U.S. sites
About Our ClientOur client is a rapidly growing, innovation-driven pharmaceutical organization headquartered in China with approximately 1,200 employees and three commercial products launched across Asia. Our client is currently expanding its clinical development footprint into the United States and is conducting two early-phase clinical trials in the US as part of its global development strategy.
As our client builds its US presence, it is seeking a qualified and experienced Clinical Research Associate (CRA) to support its expanding oncology portfolio.
Position SummaryThe Clinical Research Associate (CRA) will be responsible for the monitoring and oversight of a Phase I liquid tumour (hematologic oncology) clinical trial conducted across multiple investigational sites in the United States. This role plays a critical part in ensuring patient safety, regulatory compliance, and data integrity in accordance with Good Clinical Practice (GCP), applicable regulatory requirements, and study protocols.
The CRA will serve as the primary field-based point of contact between our client and participating clinical sites, supporting successful study execution and quality standards.
Key Responsibilities- Conduct site qualification, initiation, monitoring, and close-out visits in accordance with study plans and timelines
- Ensure the protection of study participants and the ethical conduct of the clinical trial
- Monitor compliance with study protocol, ICH-GCP guidelines, and applicable regulatory requirements
- Perform source data verification (SDV) to ensure accuracy and completeness of clinical data
- Review and ensure proper informed consent documentation for enrolled participants
- Oversee accurate reporting of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
- Ensure proper handling, storage, documentation, and accountability of investigational products
- Review and maintain site regulatory documentation and Investigator Site Files (ISF)
- Identify, document, and assist in resolving protocol deviations and data discrepancies
- Act as the primary liaison between our client and site personnel, including investigators, study coordinators, and research staff
- Support internal study team meetings and communication as required
- Bachelor’s Degree in Life Sciences, Nursing, or a related discipline
- 3–4 years of experience as a Clinical Research Associate (CRA)
- Demonstrated experience monitoring Phase I clinical trials
- Oncology clinical trial experience (solid tumour or liquid tumour preferred)
- Strong working knowledge of ICH-GCP guidelines and FDA regulations
- Willingness and ability to travel regularly to study sites across the United States
- Must be based on the East Coast of the United States
- Direct experience working on liquid tumour / hematologic oncology studies
- Located in or near Boston, Massachusetts or Princeton, New Jersey
- Fluency in Mandarin (spoken and/or written)
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