Clinical Research Associate (CRA) - Oncology (Remote)
Merck
August 26, 2026
Remote
United States
Clinical Research and Development
Candidate must reside in: Alabama, Georgia, Colorado, Massachusetts, Michigan, Maryland, Pennsylvania.
Responsibilities:
- Ensure protocol and site performance/compliance under CRA-Manager oversight (ICH-GCP, country regulations, internal policies, quality standards, adverse event reporting).
- Act as primary site contact/site manager across all study phases.
- Develop/expand clinical research territory by finding and developing new sites.
- Serve as SME for monitoring processes/systems in internal meetings.
- Manage site relationships; perform site management/monitoring per ICH-GCP, Sponsor SOPs, local laws, protocol, Site Monitoring Plan.
- Conduct remote/on-site monitoring to ensure data integrity and subject rights/safety/well-being.
- Conduct validation/initiation/monitoring/close-out visits; complete accurate visit and contact reports timely.
- Collect/review/monitor regulatory documentation for start-up/maintenance/close-out.
- Communicate with investigators/site staff on protocol conduct, recruitment/retention, deviations, documentation, audits/inspections.
- Identify/resolve quality/compliance issues and escalate as needed; partner with internal/external stakeholders (IRB/IECs, regulators, vendors).
- Maintain documentation in CTMS/eTMF; support/lead audits/inspections and co-monitoring.
Requirements/Qualifications:
- Fluent in local languages and English (verbal/written); excellent communication.
- Strong clinical research and GCP/ICH and country clinical research law knowledge; good documentation practices.
- Proven site management/monitoring skills and independent judgment; strong IT skills.
- Associate’s degree/certificate (or equivalent) + 5+ years relevant healthcare experience with 2+ years direct site management (monitoring) in bio/pharma/CRO; OR Bachelor’s degree (or above) + 2+ years.
Travel: 65%–75% (about 2–3 days/week); current driver’s license required.
Benefits (if applicable): annual bonus and long-term incentive; medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days.
Apply: https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).
Responsibilities:
- Ensure protocol and site performance/compliance under CRA-Manager oversight (ICH-GCP, country regulations, internal policies, quality standards, adverse event reporting).
- Act as primary site contact/site manager across all study phases.
- Develop/expand clinical research territory by finding and developing new sites.
- Serve as SME for monitoring processes/systems in internal meetings.
- Manage site relationships; perform site management/monitoring per ICH-GCP, Sponsor SOPs, local laws, protocol, Site Monitoring Plan.
- Conduct remote/on-site monitoring to ensure data integrity and subject rights/safety/well-being.
- Conduct validation/initiation/monitoring/close-out visits; complete accurate visit and contact reports timely.
- Collect/review/monitor regulatory documentation for start-up/maintenance/close-out.
- Communicate with investigators/site staff on protocol conduct, recruitment/retention, deviations, documentation, audits/inspections.
- Identify/resolve quality/compliance issues and escalate as needed; partner with internal/external stakeholders (IRB/IECs, regulators, vendors).
- Maintain documentation in CTMS/eTMF; support/lead audits/inspections and co-monitoring.
Requirements/Qualifications:
- Fluent in local languages and English (verbal/written); excellent communication.
- Strong clinical research and GCP/ICH and country clinical research law knowledge; good documentation practices.
- Proven site management/monitoring skills and independent judgment; strong IT skills.
- Associate’s degree/certificate (or equivalent) + 5+ years relevant healthcare experience with 2+ years direct site management (monitoring) in bio/pharma/CRO; OR Bachelor’s degree (or above) + 2+ years.
Travel: 65%–75% (about 2–3 days/week); current driver’s license required.
Benefits (if applicable): annual bonus and long-term incentive; medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days.
Apply: https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).