Clinical Research Associate (CRA) - Cardiovascular/Vaccine/Infectious Disease- Remote
Merck
September 02, 2026
Remote
United States
Clinical Research and Development
Responsibilities:
- Ensure performance and compliance of assigned protocols and sites; oversee study conduct in line with ICH/GCP, country regulations, company policies, quality standards, and adverse event reporting.
- Serve as primary site contact/site manager across all phases of clinical studies.
- Develop/expand territory by finding and developing new sites; support site selection and validation.
- Conduct remote and on-site monitoring/oversight to ensure data integrity and protection of subjects’ rights, safety, and well-being.
- Perform site visits (validation, initiation, monitoring, close-out) and ensure timely, accurate visit and contact reports.
- Collect/review/monitor regulatory documentation for start-up, maintenance, and close-out.
- Coordinate with internal teams and external partners (vendors, IRB/IECs, Regulatory Authorities) and communicate with investigators/site staff on protocol, recruitment, deviations, documentation, audits/inspections, and site performance.
- Identify/resolve quality/compliance issues and escalate per pathway; manage documentation in CTMS/eTMF; support audit/inspection and co-monitoring where needed.
Core Competencies/Skills (selected):
- Fluent English and local language; strong communication.
- Working knowledge of clinical research phases and GCP/ICH and country law.
- Good documentation practices; strong site management/monitoring judgment; IT proficiency; data analysis.
Requirements:
- Associate’s degree + 5+ years healthcare with 2+ years direct site management/monitoring (or Bachelor’s+ with 2+ years).
- Current driver’s license; ability to travel ~65–75% (about 2–3 days/week).
- Required skills include clinical trials monitoring, regulatory compliance, protocol adherence, data analysis/reporting, and preventive action.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is stated on the posting.
- Ensure performance and compliance of assigned protocols and sites; oversee study conduct in line with ICH/GCP, country regulations, company policies, quality standards, and adverse event reporting.
- Serve as primary site contact/site manager across all phases of clinical studies.
- Develop/expand territory by finding and developing new sites; support site selection and validation.
- Conduct remote and on-site monitoring/oversight to ensure data integrity and protection of subjects’ rights, safety, and well-being.
- Perform site visits (validation, initiation, monitoring, close-out) and ensure timely, accurate visit and contact reports.
- Collect/review/monitor regulatory documentation for start-up, maintenance, and close-out.
- Coordinate with internal teams and external partners (vendors, IRB/IECs, Regulatory Authorities) and communicate with investigators/site staff on protocol, recruitment, deviations, documentation, audits/inspections, and site performance.
- Identify/resolve quality/compliance issues and escalate per pathway; manage documentation in CTMS/eTMF; support audit/inspection and co-monitoring where needed.
Core Competencies/Skills (selected):
- Fluent English and local language; strong communication.
- Working knowledge of clinical research phases and GCP/ICH and country law.
- Good documentation practices; strong site management/monitoring judgment; IT proficiency; data analysis.
Requirements:
- Associate’s degree + 5+ years healthcare with 2+ years direct site management/monitoring (or Bachelor’s+ with 2+ years).
- Current driver’s license; ability to travel ~65–75% (about 2–3 days/week).
- Required skills include clinical trials monitoring, regulatory compliance, protocol adherence, data analysis/reporting, and preventive action.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is stated on the posting.