Clinical Research Associate – Immunology

MSD

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

Posted 10/7/2026full-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 monitoring processes, data analysis, and maintaining strong relationships with stakeholders across multiple protocols and sites.

Highest-signal resume keywords

Clinical Research Site ManagementICH/GCP ComplianceMonitoring SkillsPatient Recruitment ManagementRegulatory Documentation Review

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchSite ManagementMonitoring ProcessesData AnalysisGood Documentation PracticesRegulatory ComplianceAdverse Event ReportingRoot Cause AnalysisClinical Trial PhasesPerformance Metrics

Soft Skills

Time ManagementOrganizational SkillsInterpersonal SkillsProblem-Solving SkillsConflict Management

Tools & Technologies

CTMSETMFMS OfficeClinical IT Applications

Industry Keywords

BioPharmaCROImmunologyClinical TrialsRegulatory AffairsPharmacovigilanceIRBs/IECs

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Ensure performance and compliance for assigned protocols and sites in a country
Ensure study conduct compliance with ICH/GCP, country regulations, company policies and procedures, 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
Participate in internal meetings and workstreams as a subject matter expert for monitoring processes and systems
Develop strong site relationships and ensure continuity throughout all trial phases
Perform clinical study site management and monitoring activities according to applicable standards, regulations, protocols and monitoring plans
Gain an in-depth understanding of study protocols and related procedures
Coordinate and manage tasks with sponsor roles to achieve Site Ready
Participate in site selection and validation activities
Perform remote and on-site monitoring and oversight activities
Conduct validation, initiation, monitoring and close-out visits; prepare timely 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, regulatory 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
Manage and maintain information and documentation in CTMS, eTMF and other systems
Contribute to CRA team knowledge as process SME, buddy/mentor and by sharing best practices
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 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
Experience in Immunology preferred
Ability to travel domestically and internationally approximately 65% - 75% of working time; expected travelling 2-3 days/week
Current driver's license required
Fluent in Local Languages and English (verbal and written)
Good understanding and working knowledge of clinical research, phases of clinical trials, current 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 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, including MS Office and clinical IT applications on computer, tablet and mobile devices
Ability to understand and analyze data/metrics and act appropriately
Ability to manage complex issues and work in a solution-oriented manner
Root cause analysis and preventative/corrective action experience
Effective time management, organizational, interpersonal, conflict management and problem-solving skills
Ability to work independently across multiple protocols, sites and therapy areas
Ability to set priorities and handle multiple tasks simultaneously
Ability to work effectively in a matrix multicultural environment and maintain culturally sensitive working relationships
Customer focus and high quality/compliance mindset
Positive, growth mindset and ability to be self-driven
Professional demeanor and communication consistent with organizational policies and practices
US and Puerto Rico residents only
Visa sponsorship is not available

Benefits

Comp & perks

Annual bonus
Long-term incentive, if applicable
Medical healthcare benefits for employee and family
Dental healthcare benefits for employee and family
Vision healthcare benefits for employee and family
Other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate days
Sick days
Remote work arrangement
No relocation