Clinical Research Associate (CRA) - Oncology (Remote)
Merck
August 29, 2026
Remote friendly (Orange County, CA)
United States
Clinical Research and Development
Responsibilities:
- Ensure compliance of study conduct with ICH/GCP and 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 studies; take overall responsibility for allocated sites.
- Develop and expand the territory by finding and developing new clinical sites.
- Act as SME for monitoring processes and systems in internal meetings/workstreams.
- Build and maintain strong site relationships throughout the trial.
- Perform site management/monitoring in compliance with ICH-GCP, Sponsor SOPs, local laws/regulations, protocol, and Site Monitoring Plan.
- Coordinate tasks to achieve “Site Ready”; contribute to site selection and validation.
- Conduct remote and on-site monitoring/oversight to ensure complete, accurate, unbiased data and protection of subject rights, safety, and well-being.
- Conduct validation/initiation/monitoring/close-out visits; ensure timely, clear visit and non-visit contact reports.
- Collect, review, and 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, assess, resolve quality/compliance issues; escalate per defined pathway.
- Partner with internal/external stakeholders (e.g., country operations, finance, regulatory, PV, legal, vendors, IRBs/IECs, regulators).
- Manage documentation in CTMS/eTMF and other systems per timelines.
- Support/lead audit/inspection activities; perform co-monitoring when appropriate.
- Contribute to identifying new potential sites per country strategy.
Core competency expectations (required):
- Fluent in local languages and English (verbal/written); strong communication.
- Working knowledge of clinical research phases and GCP/ICH and country clinical research law.
- Knowledge of global/country clinical research guidelines; good documentation practices.
- Proven site management and monitoring skills with independent judgment.
- Strong IT skills and ability to analyze data/metrics.
- Root cause analysis; preventive/corrective action.
Behavioral expectations:
- Strong organization/time management, problem solving, conflict management.
- Works independently across multiple protocols/sites/therapy areas; accountable with urgency.
- Matrix/multicultural effectiveness and customer/compliance mind-set.
Experience/Education (required):
- Associate’s degree/certificate (scientific/healthcare) + 5+ years healthcare experience, including 2+ years direct site management (monitoring) in bio/pharma/CRO; OR Bachelor’s degree (or above) + 2+ years direct site management (monitoring) in bio/pharma/CRO.
Travel/Other:
- Travel domestically/internationally ~65–75% (~2–3 days/week); current driver’s license required.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if current employee).
- Ensure compliance of study conduct with ICH/GCP and 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 studies; take overall responsibility for allocated sites.
- Develop and expand the territory by finding and developing new clinical sites.
- Act as SME for monitoring processes and systems in internal meetings/workstreams.
- Build and maintain strong site relationships throughout the trial.
- Perform site management/monitoring in compliance with ICH-GCP, Sponsor SOPs, local laws/regulations, protocol, and Site Monitoring Plan.
- Coordinate tasks to achieve “Site Ready”; contribute to site selection and validation.
- Conduct remote and on-site monitoring/oversight to ensure complete, accurate, unbiased data and protection of subject rights, safety, and well-being.
- Conduct validation/initiation/monitoring/close-out visits; ensure timely, clear visit and non-visit contact reports.
- Collect, review, and 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, assess, resolve quality/compliance issues; escalate per defined pathway.
- Partner with internal/external stakeholders (e.g., country operations, finance, regulatory, PV, legal, vendors, IRBs/IECs, regulators).
- Manage documentation in CTMS/eTMF and other systems per timelines.
- Support/lead audit/inspection activities; perform co-monitoring when appropriate.
- Contribute to identifying new potential sites per country strategy.
Core competency expectations (required):
- Fluent in local languages and English (verbal/written); strong communication.
- Working knowledge of clinical research phases and GCP/ICH and country clinical research law.
- Knowledge of global/country clinical research guidelines; good documentation practices.
- Proven site management and monitoring skills with independent judgment.
- Strong IT skills and ability to analyze data/metrics.
- Root cause analysis; preventive/corrective action.
Behavioral expectations:
- Strong organization/time management, problem solving, conflict management.
- Works independently across multiple protocols/sites/therapy areas; accountable with urgency.
- Matrix/multicultural effectiveness and customer/compliance mind-set.
Experience/Education (required):
- Associate’s degree/certificate (scientific/healthcare) + 5+ years healthcare experience, including 2+ years direct site management (monitoring) in bio/pharma/CRO; OR Bachelor’s degree (or above) + 2+ years direct site management (monitoring) in bio/pharma/CRO.
Travel/Other:
- Travel domestically/internationally ~65–75% (~2–3 days/week); current driver’s license required.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if current employee).