Clinical Research Associate (CRA) - Oncology (Remote)
Merck
August 26, 2026
Remote friendly (Boulder, CO)
United States
Clinical Research and Development
Location requirement: Candidate must reside in AL, GA, CO, MA, MI, MD, or PA.
Role: Accountable for performance and compliance for assigned protocols and sites in a country. Ensures study conduct complies with ICH/GCP, country regulations, sponsor policies/procedures, quality standards, and adverse event reporting.
Responsibilities:
- Serve as primary site contact/site manager across all study phases; maintain site relationships.
- Conduct site management/monitoring activities per ICH-GCP, Sponsor SOPs, local laws, protocol, and site monitoring plan.
- Understand protocol and procedures; coordinate tasks to achieve “Site Ready.”
- Support site selection/validation.
- Perform remote/on-site monitoring to ensure data integrity and subject rights, safety, and well-being.
- Conduct validation/initiation/monitoring/close-out visits; complete accurate timely 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/escalate and resolve site performance/quality/compliance issues.
- Partner with internal functions and external vendors/IRBs/Regulatory Authorities for assigned sites.
- Maintain documentation in CTMS/eTMF and other systems.
- Support/lead audits/inspections; perform co-monitoring as appropriate.
Competencies/Requirements:
- Fluent in local language(s) and English (verbal/written).
- Working knowledge of clinical research and GCP/ICH and country clinical research laws.
- Good documentation practices; IT skills (MS Office and clinical systems).
- Analytical/data/metrics understanding; root cause analysis and corrective/preventive action.
- Travel 65–75% (~2–3 days/week); valid driver’s license required.
- Education/Experience: Associate’s/Certificate (scientific/healthcare) + 5 years healthcare exp including 2+ years direct site management/monitoring in bio/pharma/CRO; or Bachelor’s+ + 2+ years direct site management/monitoring.
Required skills (as listed): Accountability, Adaptability, Clinical Site Management/Study Management/Clinical Trial Monitoring, Data Analysis/Reporting, GCP/ICH, Pharmacovigilance, Protocol Adherence, Regulatory Affairs/Compliance, Preventive Action, IT Change Management.
Application: Apply via https://jobs.merck.com/us/en (application deadline stated on posting). Requisition ID: R406342.
Role: Accountable for performance and compliance for assigned protocols and sites in a country. Ensures study conduct complies with ICH/GCP, country regulations, sponsor policies/procedures, quality standards, and adverse event reporting.
Responsibilities:
- Serve as primary site contact/site manager across all study phases; maintain site relationships.
- Conduct site management/monitoring activities per ICH-GCP, Sponsor SOPs, local laws, protocol, and site monitoring plan.
- Understand protocol and procedures; coordinate tasks to achieve “Site Ready.”
- Support site selection/validation.
- Perform remote/on-site monitoring to ensure data integrity and subject rights, safety, and well-being.
- Conduct validation/initiation/monitoring/close-out visits; complete accurate timely 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/escalate and resolve site performance/quality/compliance issues.
- Partner with internal functions and external vendors/IRBs/Regulatory Authorities for assigned sites.
- Maintain documentation in CTMS/eTMF and other systems.
- Support/lead audits/inspections; perform co-monitoring as appropriate.
Competencies/Requirements:
- Fluent in local language(s) and English (verbal/written).
- Working knowledge of clinical research and GCP/ICH and country clinical research laws.
- Good documentation practices; IT skills (MS Office and clinical systems).
- Analytical/data/metrics understanding; root cause analysis and corrective/preventive action.
- Travel 65–75% (~2–3 days/week); valid driver’s license required.
- Education/Experience: Associate’s/Certificate (scientific/healthcare) + 5 years healthcare exp including 2+ years direct site management/monitoring in bio/pharma/CRO; or Bachelor’s+ + 2+ years direct site management/monitoring.
Required skills (as listed): Accountability, Adaptability, Clinical Site Management/Study Management/Clinical Trial Monitoring, Data Analysis/Reporting, GCP/ICH, Pharmacovigilance, Protocol Adherence, Regulatory Affairs/Compliance, Preventive Action, IT Change Management.
Application: Apply via https://jobs.merck.com/us/en (application deadline stated on posting). Requisition ID: R406342.