Clinical Research Associate (CRA) - Immunology-Remote
Merck
August 14, 2026
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
Responsibilities:
- Ensure compliance for assigned protocols and sites with ICH/GCP, country regulations, sponsor SOPs, quality standards, and adverse event reporting requirements.
- Serve as primary site contact and site manager through all phases of clinical research; maintain overall responsibility for allocated sites.
- Develop/expand territory by identifying and developing new sites.
- Participate in internal meetings/workstreams as SME for monitoring processes and systems.
- Develop strong site relationships and ensure continuity across trial phases.
- Conduct remote and on-site monitoring/oversight to ensure data integrity (complete, accurate, unbiased) and protection of subjects’ rights, safety, and well-being.
- Conduct site visits (validation, initiation, monitoring, close-out) and ensure timely, clear, comprehensive visit/non-visit contact reports.
- Collect, review, and monitor required regulatory documentation for start-up, maintenance, and close-out.
- Communicate with investigators/site staff on protocol conduct, recruitment/retention, deviations, regulatory documentation, audits/inspections, and site performance.
- Identify/escalate and resolve site performance/quality/compliance issues via defined CRA escalation pathway.
- Partner with internal functions and external entities (IRB/IEC, regulators, vendors) to support assigned sites.
- Maintain documentation in CTMS/eTMF and other required systems.
- Support/lead audit/inspection activities; perform co-monitoring visits as appropriate.
- Contribute to identification and development of new potential sites per country strategy.
Qualifications/Experience:
- Associate’s degree/certificate (scientific/healthcare) + 5+ years relevant healthcare experience, including 2+ years direct site management (monitoring) in bio/pharma/CRO; OR Bachelor’s degree+ + 2+ years direct site management (monitoring) in bio/pharma/CRO.
Required Skills:
- Clinical research methods; clinical trial planning/management; clinical trials monitoring; clinical site management; regulatory compliance and protocol adherence; adverse event reporting systems; preventive action/policy development; good documentation practices; IT skills; data/metrics analysis.
Preferred Skills:
- Current employees/contingent workers apply via provided links.
Travel/Other:
- ~65%-75% domestic/international travel (~2-3 days/week); current driver’s license required.
Application:
- Apply via https://jobs.merck.com/us/en (Workday Jobs Hub for current employees). Deadline stated on posting.
- Ensure compliance for assigned protocols and sites with ICH/GCP, country regulations, sponsor SOPs, quality standards, and adverse event reporting requirements.
- Serve as primary site contact and site manager through all phases of clinical research; maintain overall responsibility for allocated sites.
- Develop/expand territory by identifying and developing new sites.
- Participate in internal meetings/workstreams as SME for monitoring processes and systems.
- Develop strong site relationships and ensure continuity across trial phases.
- Conduct remote and on-site monitoring/oversight to ensure data integrity (complete, accurate, unbiased) and protection of subjects’ rights, safety, and well-being.
- Conduct site visits (validation, initiation, monitoring, close-out) and ensure timely, clear, comprehensive visit/non-visit contact reports.
- Collect, review, and monitor required regulatory documentation for start-up, maintenance, and close-out.
- Communicate with investigators/site staff on protocol conduct, recruitment/retention, deviations, regulatory documentation, audits/inspections, and site performance.
- Identify/escalate and resolve site performance/quality/compliance issues via defined CRA escalation pathway.
- Partner with internal functions and external entities (IRB/IEC, regulators, vendors) to support assigned sites.
- Maintain documentation in CTMS/eTMF and other required systems.
- Support/lead audit/inspection activities; perform co-monitoring visits as appropriate.
- Contribute to identification and development of new potential sites per country strategy.
Qualifications/Experience:
- Associate’s degree/certificate (scientific/healthcare) + 5+ years relevant healthcare experience, including 2+ years direct site management (monitoring) in bio/pharma/CRO; OR Bachelor’s degree+ + 2+ years direct site management (monitoring) in bio/pharma/CRO.
Required Skills:
- Clinical research methods; clinical trial planning/management; clinical trials monitoring; clinical site management; regulatory compliance and protocol adherence; adverse event reporting systems; preventive action/policy development; good documentation practices; IT skills; data/metrics analysis.
Preferred Skills:
- Current employees/contingent workers apply via provided links.
Travel/Other:
- ~65%-75% domestic/international travel (~2-3 days/week); current driver’s license required.
Application:
- Apply via https://jobs.merck.com/us/en (Workday Jobs Hub for current employees). Deadline stated on posting.