Clinical Research Associate – Vaccine, Infectious Disease

MSD

. Ensure performance and compliance for assigned protocols and sites in the country .

Posted 9/24/2026full-timeRemote • New Jersey • United StatesJuniorMid-Level💰 $96,200 - $151,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical research site management, ensuring compliance with ICH/GCP and local regulations while effectively managing site performance and patient recruitment. Proficient in coordinating tasks across multiple protocols and maintaining strong relationships with site staff and stakeholders.

Highest-signal resume keywords

Clinical Research Site ManagementGCP/ICH ComplianceSite Performance MonitoringRegulatory Documentation ManagementFluent in English and Local Languages

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial PhasesGood Documentation PracticesData AnalysisRoot Cause AnalysisPatient Recruitment

Soft Skills

Time ManagementOrganizational SkillsInterpersonal SkillsProblem-Solving SkillsConflict Management

Tools & Technologies

CTMSETMFMS OfficeClinical IT Applications

Certifications & Qualifications

Associate’s Degree in Scientific DisciplineCertificate in Healthcare Discipline

Industry Keywords

BioPharmaCROClinical Research GuidelinesAdverse Event Reporting

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Ensure performance and compliance for assigned protocols and sites in the country
Ensure study conduct complies with ICH/GCP, country regulations, company policies, quality standards, and adverse event reporting requirements
Act as primary site contact and site manager throughout all phases of clinical research studies
Develop and expand the clinical research territory by finding and developing new sites
Develop strong site relationships and maintain continuity throughout trial phases
Perform clinical study site management and monitoring activities
Gain in-depth understanding of study protocols and related procedures
Coordinate tasks with sponsor roles to achieve site readiness
Participate in site selection and validation activities
Perform remote and on-site monitoring and oversight activities
Conduct validation, initiation, monitoring, and close-out visits; document visit and non-visit contact reports
Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out
Communicate with investigators and site staff regarding protocol conduct, recruitment, retention, deviations, documentation, audits/inspections, and site performance
Identify, assess, resolve, and escalate site performance, quality, and compliance issues
Partner with country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, headquarters functions, vendors, IRBs/IECs, and regulatory authorities
Maintain information and documentation in CTMS, eTMF, and other systems
Contribute as a process SME, buddy/mentor, and best-practice sharer
Support or lead audit and inspection activities
Perform co-monitoring visits where appropriate
Identify potential new sites and help develop their clinical research capabilities

Requirements

What you’ll need

Associate’s degree, certificate or equivalent in a scientific / healthcare discipline plus at least 5 years of relevant healthcare experience, including at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO; OR bachelor’s degree or above plus 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, clinical trial phases, GCP/ICH, and country clinical research law and guidelines
Good understanding of global, country/regional clinical research guidelines
Hands-on knowledge of Good Documentation Practices
Proven site management skills, including site performance and patient recruitment
Demonstrated high-level monitoring skills with independent professional judgment
Good IT skills, including MS Office and clinical IT applications
Ability to understand and analyze data/metrics
Ability to manage complex issues and perform root cause analysis
Ability to implement preventative and corrective action
Effective time management, organizational, interpersonal, conflict management, problem-solving, and prioritization skills
Ability to work independently across multiple protocols, sites, and therapy areas
Ability to work effectively in a matrix multicultural environment
Commitment to customer focus and quality/compliance
Ability to travel domestically and internationally approximately 65%-75% of working time; expected travel approximately 2-3 days/week
Current driver’s license preferred
No visa sponsorship

Benefits

Comp & perks

Annual bonus
Long-term incentive, if applicable
Medical, dental, vision healthcare and other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Remote work arrangement
No relocation required