Clinical Research Associate (CRA) - Oncology (Remote)
Merck
August 29, 2026
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
Role is accountable for performance and compliance for assigned protocols and sites in a country, ensuring study conduct complies with ICH/GCP, country regulations, company policies/procedures, quality standards, and adverse event reporting requirements.
Responsibilities:
- Act as primary site contact/site manager across all study phases; manage allocated sites.
- Develop/expand territory by finding and developing new sites.
- Perform site management/monitoring (remote and on-site) to ensure data integrity and subject rights, safety, and well-being.
- Conduct visits: validation, initiation, monitoring, close-out; complete accurate visit and non-visit reports.
- Manage site tasks to achieve “Site Ready”; support site selection/validation.
- Review/monitor regulatory documentation (start-up, maintenance, close-out).
- Communicate with investigators/site staff on protocol conduct, recruitment/retention, deviations, documentation, audits/inspections, and site performance.
- Identify/assess/resolve quality/compliance issues; escalate per CRA Escalation Pathway.
- Maintain documentation in CTMS/eTMF and other systems.
- Act as SME/buddy/mentor; support and/or lead audits/inspections; perform co-monitoring visits.
Requirements/Qualifications:
- Bachelor’s (or Associate’s with equivalent) in scientific/healthcare discipline.
- Associate’s + 5+ years relevant healthcare experience including 2+ years direct site management (monitoring) in bio/pharma/CRO; OR Bachelor’s+ with 2+ years direct site management (monitoring) in bio/pharma/CRO.
Core/Required skills:
- Fluent local language(s) and English (verbal/written); strong communication.
- Working knowledge of clinical research, trial phases, GCP/ICH and country clinical research laws/guidelines.
- Good Documentation Practices; strong monitoring/site management judgment; IT skills (MS Office and clinical systems).
- Data/metrics analysis; problem-solving/root cause analysis and CAPA.
Travel: 65%-75% (about 2–3 days/week); current driver’s license required.
Application: Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).
Responsibilities:
- Act as primary site contact/site manager across all study phases; manage allocated sites.
- Develop/expand territory by finding and developing new sites.
- Perform site management/monitoring (remote and on-site) to ensure data integrity and subject rights, safety, and well-being.
- Conduct visits: validation, initiation, monitoring, close-out; complete accurate visit and non-visit reports.
- Manage site tasks to achieve “Site Ready”; support site selection/validation.
- Review/monitor regulatory documentation (start-up, maintenance, close-out).
- Communicate with investigators/site staff on protocol conduct, recruitment/retention, deviations, documentation, audits/inspections, and site performance.
- Identify/assess/resolve quality/compliance issues; escalate per CRA Escalation Pathway.
- Maintain documentation in CTMS/eTMF and other systems.
- Act as SME/buddy/mentor; support and/or lead audits/inspections; perform co-monitoring visits.
Requirements/Qualifications:
- Bachelor’s (or Associate’s with equivalent) in scientific/healthcare discipline.
- Associate’s + 5+ years relevant healthcare experience including 2+ years direct site management (monitoring) in bio/pharma/CRO; OR Bachelor’s+ with 2+ years direct site management (monitoring) in bio/pharma/CRO.
Core/Required skills:
- Fluent local language(s) and English (verbal/written); strong communication.
- Working knowledge of clinical research, trial phases, GCP/ICH and country clinical research laws/guidelines.
- Good Documentation Practices; strong monitoring/site management judgment; IT skills (MS Office and clinical systems).
- Data/metrics analysis; problem-solving/root cause analysis and CAPA.
Travel: 65%-75% (about 2–3 days/week); current driver’s license required.
Application: Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).