Clinical Research Associate (CRA) - Oncology (Remote)
Merck
August 29, 2026
Remote friendly (Laguna Hills, CA)
United States
Clinical Research and Development
Candidate must reside in: New York, New Jersey, Texas, Chicago, Southern California, or Missouri.
Role: Accountable for performance and compliance for assigned protocols and sites in a country. Under CRA-Manager oversight, ensures study conduct complies with ICH/GCP, country regulations, company policies/procedures, quality standards, and adverse event reporting.
Responsibilities:
- Primary site contact/site manager across all study phases for allocated sites.
- Develop/expand territory by finding and developing new sites.
- Serve as SME in monitoring processes and Systems.
- Build and maintain site relationships; ensure continuity.
- Perform site management/monitoring per ICH-GCP, sponsor SOPs, local laws, protocol, and site monitoring plan.
- Conduct remote and on-site monitoring; ensure data integrity and subject rights/safety/well-being.
- Conduct validation/initiation/monitoring/close-out visits; ensure accurate/timely 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 docs, audits/inspections, and performance.
- Identify/resolve site quality/compliance issues; escalate via CRA Escalation Pathway.
- Partner with internal/external stakeholders (ops, finance, regulatory, PV, legal, HQ, vendors, IRBs/IECs, regulatory authorities).
- Maintain documentation in CTMS/eTMF and other systems; support/lead audits/inspections; perform co-monitoring.
Extent of Travel: ~65–75% (about 2–3 days/week); valid driver’s license required.
Core qualifications/experience:
- Associate degree/scientific/healthcare: 5+ years relevant healthcare experience, incl. 2+ years direct site management (bio/pharma/CRO).
OR Bachelor’s (or above): 2+ years direct site management.
- Fluent in local language(s) and English (verbal/written); strong communication.
- Working knowledge of clinical research phases and GCP/ICH + country law; global/country guidelines.
- Good documentation practices; strong site management/monitoring judgment; IT skills.
Additional expectations: accountability/urgency; independent work across multiple protocols/sites; root cause analysis with corrective/preventive action; customer/compliance mindset.
Required/preferred skills (from posting): Clinical site management/monitoring, protocol adherence, data analysis/reporting, regulatory compliance, pharmacovigilance, adverse event reporting, GCP/GCDMP, and documentation.
Benefits/compensation & application:
- Eligible for annual bonus and long-term incentive (if applicable).
- Comprehensive benefits (medical/dental/vision, retirement/401(k), paid holidays/vacation, compassionate and sick days).
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline shown on posting.
Role: Accountable for performance and compliance for assigned protocols and sites in a country. Under CRA-Manager oversight, ensures study conduct complies with ICH/GCP, country regulations, company policies/procedures, quality standards, and adverse event reporting.
Responsibilities:
- Primary site contact/site manager across all study phases for allocated sites.
- Develop/expand territory by finding and developing new sites.
- Serve as SME in monitoring processes and Systems.
- Build and maintain site relationships; ensure continuity.
- Perform site management/monitoring per ICH-GCP, sponsor SOPs, local laws, protocol, and site monitoring plan.
- Conduct remote and on-site monitoring; ensure data integrity and subject rights/safety/well-being.
- Conduct validation/initiation/monitoring/close-out visits; ensure accurate/timely 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 docs, audits/inspections, and performance.
- Identify/resolve site quality/compliance issues; escalate via CRA Escalation Pathway.
- Partner with internal/external stakeholders (ops, finance, regulatory, PV, legal, HQ, vendors, IRBs/IECs, regulatory authorities).
- Maintain documentation in CTMS/eTMF and other systems; support/lead audits/inspections; perform co-monitoring.
Extent of Travel: ~65–75% (about 2–3 days/week); valid driver’s license required.
Core qualifications/experience:
- Associate degree/scientific/healthcare: 5+ years relevant healthcare experience, incl. 2+ years direct site management (bio/pharma/CRO).
OR Bachelor’s (or above): 2+ years direct site management.
- Fluent in local language(s) and English (verbal/written); strong communication.
- Working knowledge of clinical research phases and GCP/ICH + country law; global/country guidelines.
- Good documentation practices; strong site management/monitoring judgment; IT skills.
Additional expectations: accountability/urgency; independent work across multiple protocols/sites; root cause analysis with corrective/preventive action; customer/compliance mindset.
Required/preferred skills (from posting): Clinical site management/monitoring, protocol adherence, data analysis/reporting, regulatory compliance, pharmacovigilance, adverse event reporting, GCP/GCDMP, and documentation.
Benefits/compensation & application:
- Eligible for annual bonus and long-term incentive (if applicable).
- Comprehensive benefits (medical/dental/vision, retirement/401(k), paid holidays/vacation, compassionate and sick days).
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline shown on posting.