Clinical Research Associate (CRA) - Immunology-Remote
Merck
August 14, 2026
Remote friendly (Flagstaff, AZ)
United States
Clinical Research and Development
The role ensures performance and compliance for assigned clinical study protocols and sites.
Responsibilities:
- Serve as primary site contact and site manager across all study phases; maintain site relationships.
- Under CRA-Manager oversight, ensure study conduct complies with ICH-GCP, country regulations, sponsor SOPs, policies, quality standards, and adverse event reporting.
- Perform remote/on-site monitoring and oversight to ensure data integrity (complete, accurate, unbiased) and protection of subjects’ rights, safety, and well-being.
- Conduct validation, initiation, monitoring, and close-out visits; ensure accurate, timely visit/non-visit reports.
- Collect, review, and monitor required regulatory documents for start-up, maintenance, and close-out.
- Communicate with investigators/site staff on protocol conduct, recruitment/retention, deviations, documentation, audits/inspections, and site performance.
- Identify, assess, resolve, and escalate site quality/compliance issues as needed; collaborate with internal functions and external vendors/IRBs/Regulatory Authorities.
- Manage documentation in CTMS/eTMF; act as SME/buddy/mentor; support/lead audits/inspections; perform co-monitoring.
- Contribute to identification and development of new sites per country strategy.
Travel:
- Approximately 65%-75% (about 2-3 days/week); current driver’s license required.
Qualifications:
- Associate’s degree/certificate in scientific/healthcare + 5+ years relevant healthcare experience, including 2+ years direct site management/monitoring (bio/pharma/CRO).
OR Bachelor’s degree (or above) + 2+ years direct site management/monitoring (bio/pharma/CRO).
Core competency expectations (high level):
- Fluency in local language(s) and English; strong communication.
- Working knowledge of clinical research and GCP/ICH and country regulations; good documentation practices.
- Site management and independent monitoring judgment; strong IT; data analysis; root-cause/problem solving.
Required skills (as listed):
- Adverse Event Reporting System, Clinical Trials Monitoring, Clinical Site Management, Clinical Study Management, Protocol Adherence, Regulatory/Compliance, Preventive Action, Core Competencies.
Benefits:
- Eligible for annual bonus and long-term incentive (if applicable); comprehensive benefits package including medical/dental/vision, retirement (401(k)), paid holidays/vacation, and sick/compassionate days.
Application:
- Apply at https://jobs.merck.com/us/en (deadline stated on posting).
Responsibilities:
- Serve as primary site contact and site manager across all study phases; maintain site relationships.
- Under CRA-Manager oversight, ensure study conduct complies with ICH-GCP, country regulations, sponsor SOPs, policies, quality standards, and adverse event reporting.
- Perform remote/on-site monitoring and oversight to ensure data integrity (complete, accurate, unbiased) and protection of subjects’ rights, safety, and well-being.
- Conduct validation, initiation, monitoring, and close-out visits; ensure accurate, timely visit/non-visit reports.
- Collect, review, and monitor required regulatory documents for start-up, maintenance, and close-out.
- Communicate with investigators/site staff on protocol conduct, recruitment/retention, deviations, documentation, audits/inspections, and site performance.
- Identify, assess, resolve, and escalate site quality/compliance issues as needed; collaborate with internal functions and external vendors/IRBs/Regulatory Authorities.
- Manage documentation in CTMS/eTMF; act as SME/buddy/mentor; support/lead audits/inspections; perform co-monitoring.
- Contribute to identification and development of new sites per country strategy.
Travel:
- Approximately 65%-75% (about 2-3 days/week); current driver’s license required.
Qualifications:
- Associate’s degree/certificate in scientific/healthcare + 5+ years relevant healthcare experience, including 2+ years direct site management/monitoring (bio/pharma/CRO).
OR Bachelor’s degree (or above) + 2+ years direct site management/monitoring (bio/pharma/CRO).
Core competency expectations (high level):
- Fluency in local language(s) and English; strong communication.
- Working knowledge of clinical research and GCP/ICH and country regulations; good documentation practices.
- Site management and independent monitoring judgment; strong IT; data analysis; root-cause/problem solving.
Required skills (as listed):
- Adverse Event Reporting System, Clinical Trials Monitoring, Clinical Site Management, Clinical Study Management, Protocol Adherence, Regulatory/Compliance, Preventive Action, Core Competencies.
Benefits:
- Eligible for annual bonus and long-term incentive (if applicable); comprehensive benefits package including medical/dental/vision, retirement (401(k)), paid holidays/vacation, and sick/compassionate days.
Application:
- Apply at https://jobs.merck.com/us/en (deadline stated on posting).