Clinical Research Associate (CRA) - Oncology (Remote)
Merck
August 18, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Responsibilities:
- Ensure performance and compliance for assigned clinical research protocols and sites under CRA-Manager oversight, including ICH/GCP, country regulations, internal policies/procedures, quality standards, and adverse event reporting.
- Act as primary site contact/site manager across all study phases; take overall responsibility for allocated sites.
- Develop and expand territory by finding and developing new clinical sites.
- Act as SME for internal meetings/workstreams for monitoring processes/systems.
- Build/maintain site relationships; perform site management/monitoring per ICH-GCP, sponsor SOPs, local laws, protocol, and site monitoring plan.
- Gain in-depth understanding of protocol; coordinate tasks to achieve Site Ready.
- Support site selection/validation; conduct remote and on-site monitoring to ensure data integrity and subject rights/safety/well-being.
- Conduct validation/initiation/monitoring/close-out visits; ensure timely, accurate visit and 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, regulatory documentation, audits/inspections, and site performance.
- Identify/resolve site quality/compliance issues and escalate appropriately.
- Partner with internal functions (GCTO country ops, finance, regulatory, pharmacovigilance, legal, regional ops) and external stakeholders (vendors, IRB/IECs, regulatory authorities).
- Maintain documentation in CTMS/eTMF and other systems.
- Support/lead audits/inspections; perform co-monitoring visits.
Core Competency Expectations/Required Skills:
- Fluent in local languages and English; strong communication.
- Working knowledge of clinical research phases and GCP/ICH and country laws; global/country guidelines.
- Good documentation practices; site management and independent monitoring judgment.
- Strong IT skills; analyze data/metrics; root cause analysis and CAPA.
Behavioral Expectations:
- Time management, organization, conflict/problem solving; accountability/urgency.
- Independent, solution-oriented; culturally sensitive matrix collaboration.
Experience/Education:
- Associate’s degree/scientific or healthcare discipline + 5+ years relevant healthcare experience, including 2+ years direct bio/pharma/CRO site management (monitoring).
OR Bachelor’s degree (or above) + 2+ years direct site management (monitoring).
Travel/Logistics:
- Ability to travel domestically/internationally ~65–75% (about 2–3 days/week); valid driver’s license required.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.
- Ensure performance and compliance for assigned clinical research protocols and sites under CRA-Manager oversight, including ICH/GCP, country regulations, internal policies/procedures, quality standards, and adverse event reporting.
- Act as primary site contact/site manager across all study phases; take overall responsibility for allocated sites.
- Develop and expand territory by finding and developing new clinical sites.
- Act as SME for internal meetings/workstreams for monitoring processes/systems.
- Build/maintain site relationships; perform site management/monitoring per ICH-GCP, sponsor SOPs, local laws, protocol, and site monitoring plan.
- Gain in-depth understanding of protocol; coordinate tasks to achieve Site Ready.
- Support site selection/validation; conduct remote and on-site monitoring to ensure data integrity and subject rights/safety/well-being.
- Conduct validation/initiation/monitoring/close-out visits; ensure timely, accurate visit and 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, regulatory documentation, audits/inspections, and site performance.
- Identify/resolve site quality/compliance issues and escalate appropriately.
- Partner with internal functions (GCTO country ops, finance, regulatory, pharmacovigilance, legal, regional ops) and external stakeholders (vendors, IRB/IECs, regulatory authorities).
- Maintain documentation in CTMS/eTMF and other systems.
- Support/lead audits/inspections; perform co-monitoring visits.
Core Competency Expectations/Required Skills:
- Fluent in local languages and English; strong communication.
- Working knowledge of clinical research phases and GCP/ICH and country laws; global/country guidelines.
- Good documentation practices; site management and independent monitoring judgment.
- Strong IT skills; analyze data/metrics; root cause analysis and CAPA.
Behavioral Expectations:
- Time management, organization, conflict/problem solving; accountability/urgency.
- Independent, solution-oriented; culturally sensitive matrix collaboration.
Experience/Education:
- Associate’s degree/scientific or healthcare discipline + 5+ years relevant healthcare experience, including 2+ years direct bio/pharma/CRO site management (monitoring).
OR Bachelor’s degree (or above) + 2+ years direct site management (monitoring).
Travel/Logistics:
- Ability to travel domestically/internationally ~65–75% (about 2–3 days/week); valid driver’s license required.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.