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MSD
MSD
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MSD is a global biopharmaceutical company advancing medicines and vaccines for major health challenges, including cancer, infectious diseases, cardiovascular and metabolic conditions, and prevention-focused care. Known as Merck & Co., Inc. in the United States, Canada, and Puerto Rico, MSD combines scientific research with development and commercial expertise to bring healthcare solutions to people and animals.

Its work spans Human Health, Animal Health, and Research & Development, creating opportunities for professionals across scientific, clinical, commercial, operational, and corporate teams. With activities in regions around the world, MSD’s careers reflect its focus on research, collaboration, inclusion, and responsible progress in global health.

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Clinical Research Associate - Immunology (Remote, New Jersey)

Remote Clinical Research Associate role supporting immunology trials for MSD, with responsibility for site oversight, compliance, documentation, and investigator relationships. Requires approximately 65–75% domestic and international travel.

USUnited StatesNJNew Jersey
$96,200 – $151,400 / year
RemoteFull-timeJuniorMiddleEnglish RequiredClinical Research
Google Cloud Platform

Description

  • Maintain performance and compliance across assigned protocols and clinical sites
  • Ensure studies follow ICH/GCP, local regulations, company policies, quality standards, and adverse event reporting requirements
  • Serve as the primary site contact and manager throughout each phase of clinical research studies
  • Expand the clinical research territory by identifying and developing new sites
  • Contribute subject-matter expertise on monitoring processes and systems in internal meetings and workstreams
  • Build strong site relationships and maintain continuity across trial phases
  • Manage and monitor clinical study sites in accordance with applicable requirements
  • Develop a thorough understanding of study protocols and related procedures
  • Coordinate with sponsor functions to achieve site readiness
  • Support site selection and validation activities
  • Conduct remote and on-site monitoring and oversight
  • Complete validation, initiation, monitoring, and close-out visits
  • Produce clear, comprehensive, and accurate visit and non-visit contact reports
  • Collect, review, and monitor regulatory documentation through study start-up, maintenance, and close-out
  • Communicate with investigators and site staff about protocol conduct, recruitment, retention, deviations, documentation, audits, inspections, and performance
  • Identify, evaluate, resolve, and escalate site performance, quality, and compliance issues
  • Collaborate with country operations, finance, regulatory affairs, pharmacovigilance, legal, regional and headquarters teams, vendors, IRBs/IECs, and regulatory authorities
  • Maintain study information and documentation in CTMS, eTMF, and other systems
  • Share knowledge with the CRA team as a subject-matter expert, buddy or mentor, and best-practice contributor
  • Support or lead audit and inspection activities
  • Conduct co-monitoring visits when appropriate
  • Identify prospective sites and help strengthen their clinical research capabilities

Requirements

  • Associate degree, certificate, or equivalent in a scientific or healthcare discipline with at least 5 years of relevant healthcare experience, including 2 years of direct site-monitoring experience in a biotechnology, pharmaceutical, or CRO setting; alternatively, a bachelor's degree or higher with at least 2 years of direct site-monitoring experience in a biotechnology, pharmaceutical, or CRO setting
  • Immunology experience is preferred
  • Ability to travel domestically and internationally for approximately 65%–75% of working time, typically 2–3 days per week
  • Valid driver's license
  • Fluency in local languages and English, both spoken and written
  • Understanding of clinical research, trial phases, GCP/ICH, and country-specific clinical research laws and guidelines
  • Understanding of global and country or regional clinical research guidelines
  • Knowledge of Good Documentation Practices
  • Demonstrated site management ability, including site performance and patient recruitment
  • Advanced monitoring skills and independent professional judgment
  • Strong IT skills, including Microsoft Office and clinical IT applications
  • Ability to interpret and analyze data and metrics
  • Ability to manage complex issues and conduct root cause analysis
  • Effective time management, organization, interpersonal communication, conflict management, and problem-solving skills
  • Ability to work independently across multiple protocols, sites, and therapy areas
  • Ability to work effectively in a multicultural matrix environment
  • Commitment to customer focus, quality, and 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

  • Annual bonus
  • Long-term incentive, where applicable
  • Medical, dental, and vision coverage
  • Additional insurance benefits for employees and families
  • Retirement benefits, including a 401(k) plan
  • Paid holidays
  • Vacation time
  • Compassionate leave
  • Sick leave
  • Remote work arrangement
  • No relocation

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