Clinical Research Associate – Immunology

MSD

. Ensure performance and compliance for assigned protocols and sites .

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 and Site Management, ensuring compliance with GCP/ICH guidelines and effective monitoring of clinical trials. Proven ability to build strong site relationships and manage complex issues while maintaining high standards of quality and compliance.

Highest-signal resume keywords

Clinical Site ManagementGood Clinical Practice (GCP)Site Performance ManagementClinical Trials MonitoringRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchClinical Trial PlanningAdverse Event Reporting SystemGood Documentation PracticesData AnalysisMonitoring SkillsPatient RecruitmentProtocol AdherenceRegulatory Affairs ManagementRemote Monitoring

Soft Skills

Effective Time ManagementOrganizational SkillsInterpersonal SkillsProblem-Solving SkillsConflict Management

Tools & Technologies

CTMSETMFMS OfficeClinical IT Applications

Industry Keywords

BioPharmaCROImmunologyClinical Study ManagementCultural AwarenessMatrix Management

About the role

Key responsibilities & impact

Ensure performance and compliance for assigned protocols and sites
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
Participate in internal meetings and workstreams as a subject matter expert for monitoring processes and systems
Develop strong site relationships and ensure continuity throughout trial phases
Perform clinical study site management and monitoring in compliance with applicable requirements
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
Prepare clear, comprehensive, and accurate 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 to CRA team knowledge as 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
Experience in Immunology preferred
Ability to travel domestically and internationally approximately 65%-75% of working time; expected travel approximately 2-3 days/week
Current driver's license required
Fluent in local languages and English, verbal and written
Understanding of clinical research, clinical trial phases, GCP/ICH, and country clinical research laws and guidelines
Understanding of global, country/regional clinical research guidelines
Knowledge of Good Documentation Practices
Proven site management skills, including site performance and patient recruitment
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
Effective time management, organizational, interpersonal, conflict management, and problem-solving 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
Adverse Event Reporting System
Clinical Research
Clinical Research Methods
Clinical Site Management
Clinical Study Management
Clinical Trial Planning
Clinical Trials Monitoring
Cultural Awareness
Customer Centricity
Document Management
Good Clinical Data Management Practice (GCDMP)
Good Clinical Practice (GCP)
Matrix Management
On Site Management
Pharmaceutics
Protocol Adherence
Protocol Review
Regulatory Affairs Management
Regulatory Compliance
Regulatory Inspections
Relationship Building
Remote Monitoring
Site Management
Study Design

Benefits

Comp & perks

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