Clinical Research Associate, Cardiovascular, Vaccine, Infectious Disease

MSD

Clinical Research Associate accountable for clinical trial compliance and performance management at allocated sites. Actively develops new sites and oversees study conduct per ICH/GCP guidelines.

Posted 7/9/2026full-timeRemote • Florida, Illinois, New Jersey, New York • 🇺🇸 United StatesJuniorMid-Level💰 $96,200 - $151,400 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

The role is accountable for performance and compliance for assigned protocols and sites in a country.
Under the oversight of the CRA-Manager the person ensures compliance of study conduct with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
Actively develops and expands the territory for clinical research, finding and developing new sites.
Performs remote and on-site monitoring & oversight activities to ensure:
Data generated at site are complete, accurate and unbiased.
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.
Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
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.

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)
Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
Hands on knowledge of Good Documentation Practices.
Proven Skills in Site Management including management of site performance and patient recruitment.
Demonstrated high level of monitoring skill with independent professional judgment.
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.
Ability to understand and analyze data/metrics and act appropriately.
Capable of managing complex issues, works in a solution-oriented manner.
Demonstrates commitment to Customer focus.

Benefits

Comp & perks

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Clinical ResearchSite MonitoringGood Clinical Practice (GCP)Good Documentation PracticesRegulatory CompliancePatient RecruitmentData AnalysisClinical Trial PhasesSite Performance ManagementHealthcare Discipline

Soft Skills

Solution-OrientedCommitment to Customer Focus