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Clinical Research Associate (CRA) – Oncology

MSD · United States

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Website: merck.com

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Role overview (listing rewrite)

MSD seeks a Clinical Research Associate specializing in Oncology to join our clinical research team across the United States. In this full-time position, you'll serve as the primary site manager for critical cancer research studies, ensuring strict regulatory compliance while building and maintaining relationships with leading research institutions. The Opportunity Lead the charge in advancing oncology research by managing clinical trial sites with excellence and precision. You'll coordinate all aspects of site performance, from pre-study validation through post-trial closeout, ensuring data integrity and participant safety. This role combines strategic site development—identifying and cultivating new research partnerships—with hands-on oversight of ongoing trials, making you essential to bringing breakthrough oncology treatments closer to patients who need them. Your Responsibilities Oversee site monitoring activities both remotely and in-person, verifying that data collected is complete, accurate, and compliant with study protocols and regulatory requirements Establish and strengthen relationships with site investigators and staff, serving as the primary contact throughout all phases of assigned studies Conduct site visits for validation, initiation, periodic monitoring checks, and study closeout, documenting findings in comprehensive reports Ensure full compliance with Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and applicable country regulations Manage regulatory documentation collection and maintenance for study startup, ongoing conduct, and completion Address site performance challenges and compliance gaps through root cause analysis and corrective action implementation Identify, evaluate, and cultivate new clinical research sites to expand oncology research capacity within assigned territories Collaborate across sponsor teams and external partners—including regulatory authorities, ethics committees, and vendors—to support assigned sites Who We're Looking For Associate degree in a scientific or healthcare field plus 5+ years of healthcare experience (including 2+ years of direct site management at a biotech, pharmaceutical, or contract research organization) OR Bachelor's degree with 2+ years of direct site management experience Expert-level understanding of clinical research operations, trial phases, GCP/ICH standards, and regulatory frameworks Proven track record managing clinical trial sites, optimizing recruitment, and resolving performance issues Fluent English communication skills, both written and verbal, with ability to explain complex clinical and regulatory concepts Proficiency with Microsoft Office, clinical data management systems,…

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Generated for personal interview prep · 2026-07-17 UTC · getajob.ai