Clinical Research Associate (CRA) - Cardiovascular/Vaccine/Infectious Disease- Remote
Merck
September 02, 2026
Remote
United States
Clinical Research and Development
Responsibilities:
- Accountable for performance and compliance for assigned protocols and sites in a country; ensure study conduct complies with ICH/GCP, country regulations, company policies/procedures, quality standards, and adverse event reporting requirements.
- Serve as primary site contact and site manager across all phases of clinical research; ensure continuity of site relationships.
- Develop and expand territory by finding and developing new sites; contribute to site selection/validation.
- Perform remote and on-site monitoring/oversight to ensure data completeness/accuracy/unbiased reporting and protection of subjects’ rights, safety, and well-being.
- Conduct validation, initiation, monitoring, and close-out visits; ensure accurate/timely visit and non-visit contact reports.
- Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out.
- Communicate with investigators/site staff on protocol conduct, recruitment/retention, protocol deviations, regulatory documentation, audits/inspections, and site performance.
- Identify, assess, resolve, and escalate site quality/compliance issues per escalation pathway.
- Maintain documentation in CTMS/eTMF and other systems; act as process SME/buddy/mentor.
- Support/lead audits/inspections; perform co-monitoring visits as appropriate.
Qualifications:
- Fluent in local languages and English (verbal/written) with strong communication skills.
- Working knowledge of clinical research, trial phases, GCP/ICH, and country clinical research laws; global/country/regional guidelines.
- Hands-on knowledge of Good Documentation Practices; proven site management skills (site performance/patient recruitment).
- Demonstrated monitoring skill with independent judgment; good IT skills; ability to analyze data/metrics.
- Root cause analysis and implementation of preventive/corrective action.
Experience/Education:
- Associate’s (scientific/healthcare) + 5+ years healthcare experience including 2+ years direct site management/monitoring in bio/pharma/CRO; or Bachelor’s (or above) + 2+ years.
Required skills: Adverse event reporting systems, clinical research methods, clinical site/study management, clinical trial planning/monitoring, core competencies, data analysis/reporting, early clinical development, policy development, preventive action, protocol adherence, regulatory compliance, site management.
Travel/Other:
- Travel 65–75% (~2–3 days/week); current driver’s license required.
Application:
- Apply via https://jobs.merck.com/us/en (application deadline per posting). Requisition ID: R406347.
- Accountable for performance and compliance for assigned protocols and sites in a country; ensure study conduct complies with ICH/GCP, country regulations, company policies/procedures, quality standards, and adverse event reporting requirements.
- Serve as primary site contact and site manager across all phases of clinical research; ensure continuity of site relationships.
- Develop and expand territory by finding and developing new sites; contribute to site selection/validation.
- Perform remote and on-site monitoring/oversight to ensure data completeness/accuracy/unbiased reporting and protection of subjects’ rights, safety, and well-being.
- Conduct validation, initiation, monitoring, and close-out visits; ensure accurate/timely visit and non-visit contact reports.
- Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out.
- Communicate with investigators/site staff on protocol conduct, recruitment/retention, protocol deviations, regulatory documentation, audits/inspections, and site performance.
- Identify, assess, resolve, and escalate site quality/compliance issues per escalation pathway.
- Maintain documentation in CTMS/eTMF and other systems; act as process SME/buddy/mentor.
- Support/lead audits/inspections; perform co-monitoring visits as appropriate.
Qualifications:
- Fluent in local languages and English (verbal/written) with strong communication skills.
- Working knowledge of clinical research, trial phases, GCP/ICH, and country clinical research laws; global/country/regional guidelines.
- Hands-on knowledge of Good Documentation Practices; proven site management skills (site performance/patient recruitment).
- Demonstrated monitoring skill with independent judgment; good IT skills; ability to analyze data/metrics.
- Root cause analysis and implementation of preventive/corrective action.
Experience/Education:
- Associate’s (scientific/healthcare) + 5+ years healthcare experience including 2+ years direct site management/monitoring in bio/pharma/CRO; or Bachelor’s (or above) + 2+ years.
Required skills: Adverse event reporting systems, clinical research methods, clinical site/study management, clinical trial planning/monitoring, core competencies, data analysis/reporting, early clinical development, policy development, preventive action, protocol adherence, regulatory compliance, site management.
Travel/Other:
- Travel 65–75% (~2–3 days/week); current driver’s license required.
Application:
- Apply via https://jobs.merck.com/us/en (application deadline per posting). Requisition ID: R406347.