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 for assigned protocols/sites under CRA-Manager oversight, including ICH/GCP, country regulations, SOPs, quality standards, and adverse event reporting.
- Serve as primary site contact/site manager across all study phases; develop and expand territory by finding/developing new sites.
- Conduct remote and on-site monitoring to ensure data completeness/accuracy, and subject rights, safety, and well-being.
- Perform validation, initiation, monitoring, and close-out site visits; prepare timely visit/non-visit 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, documentation, audits/inspections, and site performance.
- Identify/resolve site quality/compliance issues and escalate via defined CRA pathway.
- Maintain CTMS/eTMF and systems per timelines; support/lead audits/inspections and co-monitoring as appropriate.
Extent of Travel / License:
- Travel domestically/internationally ~65–75% (~2–3 days/week); current driver’s license required.
Qualifications / Experience:
- Associate’s degree/certificate (scientific/healthcare) + 5+ years relevant 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, clinical research methods, clinical site/study management, trial planning, monitoring, data analysis/reporting, preventive action, protocol adherence, regulatory compliance, site management.
Preferred Skills:
- Not specified.
Benefits (if applicable):
- Medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days.
Application:
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is stated on the posting.
- Ensure performance and compliance for assigned protocols/sites under CRA-Manager oversight, including ICH/GCP, country regulations, SOPs, quality standards, and adverse event reporting.
- Serve as primary site contact/site manager across all study phases; develop and expand territory by finding/developing new sites.
- Conduct remote and on-site monitoring to ensure data completeness/accuracy, and subject rights, safety, and well-being.
- Perform validation, initiation, monitoring, and close-out site visits; prepare timely visit/non-visit 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, documentation, audits/inspections, and site performance.
- Identify/resolve site quality/compliance issues and escalate via defined CRA pathway.
- Maintain CTMS/eTMF and systems per timelines; support/lead audits/inspections and co-monitoring as appropriate.
Extent of Travel / License:
- Travel domestically/internationally ~65–75% (~2–3 days/week); current driver’s license required.
Qualifications / Experience:
- Associate’s degree/certificate (scientific/healthcare) + 5+ years relevant 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, clinical research methods, clinical site/study management, trial planning, monitoring, data analysis/reporting, preventive action, protocol adherence, regulatory compliance, site management.
Preferred Skills:
- Not specified.
Benefits (if applicable):
- Medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days.
Application:
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is stated on the posting.