Clinical Research Associate, Oncology

MSD

Responsible for managing clinical research compliance and performance across multiple sites in the USA. Collaborating with teams to ensure adherence to regulations and quality standards in clinical trials.

Posted 7/9/2026full-timeRemote • California, Colorado, Illinois, Maryland, Massachusetts, Missouri, Montana, New Jersey, New York, Pennsylvania, Texas • 🇺🇸 United StatesJuniorMid-Level💰 $96,200 - $151,400 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
Gains an in-depth understanding of the study protocol and related procedures.
Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
Performs remote and on-site monitoring & oversight activities using various tools to ensure Data generated at site are complete, accurate and unbiased and subjects’ right, safety and well-being are protected.
Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA-Manager, CRM, TA Head and CRD as needed.
Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.
Supports and/or leads audit/inspection activities as needed.
Performs co-monitoring visits where appropriate.
Following the country strategy defined by CRD and/or CRA-Manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.

Requirements

What you’ll need

Associate's degree, certificate or equivalent in a scientific / healthcare discipline together with at least 5 years of relevant experience in the healthcare field, including at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO
or Bachelor’s degree (or above) together with at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO
Fluent in Local Languages and English (verbal and written)
Excellent communication skills, including the ability to understand and present technical information effectively.
Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
Proven Skills in Site Management including management of site performance and patient recruitment.
Demonstrated high level of monitoring skill with independent professional judgment.

Benefits

Comp & perks

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays, vacation, and compassionate and sick days
annual bonus and long-term incentive, if applicable

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Site MonitoringRegulatory DocumentationClinical Research KnowledgeStudy Protocol UnderstandingData Accuracy Assurance

Soft Skills

Excellent Communication SkillsProblem-SolvingCollaboration