Clinical Research Associate (CRA) - Oncology (Remote)
Merck
September 03, 2026
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
The role ensures performance and compliance for assigned clinical study protocols and sites in a country.
Responsibilities:
- Act as primary site contact/site manager across all study phases; ensure site relationship continuity.
- Ensure study conduct complies with ICH-GCP, sponsor SOPs, local laws, protocol, site monitoring plan, and adverse event reporting.
- Perform remote and on-site monitoring/oversight; conduct validation, initiation, monitoring, and close-out visits; ensure accurate, timely visit/non-visit reports.
- Manage site start-up/maintenance/close-out regulatory documentation; communicate protocol, recruitment/retention, deviations, audits/inspections, and site performance issues.
- Identify/assess/resolve site quality or compliance issues; escalate per CRA Escalation Pathway as needed.
- Maintain required study systems documentation in CTMS/eTMF and other systems.
- Support/lead audits/inspections and perform co-monitoring as appropriate.
- Support growth of territory by identifying and developing new sites; follow country strategy.
Qualifications/Requirements:
- Fluent in local language(s) and English (verbal/written); strong technical communication.
- Working knowledge of clinical research and GCP/ICH and country regulations/guidelines.
- Hands-on Good Documentation Practices; strong site management/monitoring skills and independent judgment.
- Good IT skills; ability to analyze data/metrics and perform root-cause analysis and corrective/preventive actions.
- Associate’s degree/certificate (scientific/healthcare) + 5+ years relevant healthcare experience, including 2+ years direct site management (bio/pharma/CRO), or Bachelor’s degree (or above) + 2+ years direct site management (bio/pharma/CRO).
- Travel: ~65–75% (about 2–3 days/week); current driver’s license required.
Preferred/Skills:
- Required skills include clinical trials monitoring/site management, protocol adherence, regulatory compliance, pharmacovigilance, adverse event reporting systems, and data analysis/reporting.
Compensation/Benefits (if applicable):
- Annual bonus and long-term incentive, if applicable; comprehensive benefits including medical/dental/vision and 401(k) (per posting).
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Apply by the deadline stated on the posting.
Responsibilities:
- Act as primary site contact/site manager across all study phases; ensure site relationship continuity.
- Ensure study conduct complies with ICH-GCP, sponsor SOPs, local laws, protocol, site monitoring plan, and adverse event reporting.
- Perform remote and on-site monitoring/oversight; conduct validation, initiation, monitoring, and close-out visits; ensure accurate, timely visit/non-visit reports.
- Manage site start-up/maintenance/close-out regulatory documentation; communicate protocol, recruitment/retention, deviations, audits/inspections, and site performance issues.
- Identify/assess/resolve site quality or compliance issues; escalate per CRA Escalation Pathway as needed.
- Maintain required study systems documentation in CTMS/eTMF and other systems.
- Support/lead audits/inspections and perform co-monitoring as appropriate.
- Support growth of territory by identifying and developing new sites; follow country strategy.
Qualifications/Requirements:
- Fluent in local language(s) and English (verbal/written); strong technical communication.
- Working knowledge of clinical research and GCP/ICH and country regulations/guidelines.
- Hands-on Good Documentation Practices; strong site management/monitoring skills and independent judgment.
- Good IT skills; ability to analyze data/metrics and perform root-cause analysis and corrective/preventive actions.
- Associate’s degree/certificate (scientific/healthcare) + 5+ years relevant healthcare experience, including 2+ years direct site management (bio/pharma/CRO), or Bachelor’s degree (or above) + 2+ years direct site management (bio/pharma/CRO).
- Travel: ~65–75% (about 2–3 days/week); current driver’s license required.
Preferred/Skills:
- Required skills include clinical trials monitoring/site management, protocol adherence, regulatory compliance, pharmacovigilance, adverse event reporting systems, and data analysis/reporting.
Compensation/Benefits (if applicable):
- Annual bonus and long-term incentive, if applicable; comprehensive benefits including medical/dental/vision and 401(k) (per posting).
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Apply by the deadline stated on the posting.