Clinical Research Associate (CRA) - Oncology (Remote)
Merck
August 26, 2026
Remote friendly (Colorado, United States)
United States
Clinical Research and Development
Candidate must reside in: Alabama, Georgia, Colorado, Massachusetts, Michigan, Maryland, Pennsylvania.
Responsibilities:
- Accountable for performance and compliance for assigned protocols/sites in a country; ensure study conduct compliant with ICH/GCP, country regulations, policies/procedures, quality standards, and adverse event reporting.
- Primary site contact; act as site manager across all phases; oversee allocated sites.
- Develop/expand territory by finding and developing new sites; contribute to site selection/validation.
- Perform remote and on-site monitoring to ensure data integrity and subject rights, safety, and well-being.
- Conduct validation/initiation/monitoring/close-out visits; complete timely, accurate visit and contact reports.
- Collect/review/monitor regulatory documentation for start-up, maintenance, and close-out.
- Communicate with investigators/site staff on protocol conduct, recruitment/retention, deviations, regulatory docs, audits/inspections, and site performance.
- Identify/assess/resolve site quality/compliance issues; escalate per CRA Escalation Pathway.
- Manage/document systems (CTMS, eTMF, etc.); support/lead audits/inspections; perform co-monitoring as appropriate; act as SME/buddy/mentor.
Travel: 65–75% (~2–3 days/week). Current driver’s license required.
Core expectations: fluent local language(s) and English; strong clinical research/GCP/ICH and country law knowledge; good documentation practices; strong site management/independent monitoring judgment; strong IT skills; data/metrics analysis; root cause analysis with corrective/preventive actions.
Experience/education:
- Associate’s (scientific/healthcare) + 5+ years relevant healthcare experience, including 2+ years direct site management in bio/pharma/CRO; OR
- Bachelor’s (or above) + 2+ years direct site management in bio/pharma/CRO.
Required skills: accountability, clinical research methods, clinical site/clinical study management, clinical trial planning/monitoring, data analysis/reporting, GCP/ICH, adverse event reporting, regulatory compliance.
Apply: https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).
Responsibilities:
- Accountable for performance and compliance for assigned protocols/sites in a country; ensure study conduct compliant with ICH/GCP, country regulations, policies/procedures, quality standards, and adverse event reporting.
- Primary site contact; act as site manager across all phases; oversee allocated sites.
- Develop/expand territory by finding and developing new sites; contribute to site selection/validation.
- Perform remote and on-site monitoring to ensure data integrity and subject rights, safety, and well-being.
- Conduct validation/initiation/monitoring/close-out visits; complete timely, accurate visit and contact reports.
- Collect/review/monitor regulatory documentation for start-up, maintenance, and close-out.
- Communicate with investigators/site staff on protocol conduct, recruitment/retention, deviations, regulatory docs, audits/inspections, and site performance.
- Identify/assess/resolve site quality/compliance issues; escalate per CRA Escalation Pathway.
- Manage/document systems (CTMS, eTMF, etc.); support/lead audits/inspections; perform co-monitoring as appropriate; act as SME/buddy/mentor.
Travel: 65–75% (~2–3 days/week). Current driver’s license required.
Core expectations: fluent local language(s) and English; strong clinical research/GCP/ICH and country law knowledge; good documentation practices; strong site management/independent monitoring judgment; strong IT skills; data/metrics analysis; root cause analysis with corrective/preventive actions.
Experience/education:
- Associate’s (scientific/healthcare) + 5+ years relevant healthcare experience, including 2+ years direct site management in bio/pharma/CRO; OR
- Bachelor’s (or above) + 2+ years direct site management in bio/pharma/CRO.
Required skills: accountability, clinical research methods, clinical site/clinical study management, clinical trial planning/monitoring, data analysis/reporting, GCP/ICH, adverse event reporting, regulatory compliance.
Apply: https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).