Clinical Research Associate (CRA) - Immunology-Remote
Merck
August 14, 2026
Remote friendly (Boulder, CO)
United States
Clinical Research and Development
Role Overview
- Accountable for performance and compliance for assigned protocols and sites; ensures study conduct complies with ICH/GCP and country regulations, company policies/procedures, quality standards, and adverse event reporting requirements.
- Primary site contact and site manager across all phases of clinical research studies.
- Develop and expand territory by finding and developing new sites.
- Participate in internal meetings/workstreams as SME for monitoring processes/systems.
Responsibilities
- Develop strong site relationships and ensure continuity throughout the trial.
- Perform site management/monitoring activities per ICH-GCP, sponsor SOPs, local laws, protocol, site monitoring plan.
- Understand study protocol and procedures; coordinate tasks to achieve “Site Ready.”
- Contribute to site selection/validation.
- Conduct remote and on-site monitoring/oversight to ensure data integrity, subject rights/safety/well-being.
- Conduct validation, initiation, monitoring, close-out visits; ensure timely, accurate visit and non-visit reports.
- Collect/review/monitor required regulatory documentation (start-up, maintenance, close-out).
- Communicate with investigators/site staff on protocol conduct, recruitment/retention, deviations, regulatory documentation, audits/inspections, site performance.
- Identify/escalate and resolve site performance/quality/compliance problems via CRA escalation pathway.
- Partner with internal functions and external stakeholders (vendors, IRB/IECs, regulatory authorities).
- Maintain documentation in CTMS/eTMF and systems per timelines; act as SME/buddy/mentor.
- Support/lead audits/inspections; perform co-monitoring when appropriate.
Travel: Approx. 65–75% (about 2–3 days/week). Current driver’s license required.
Core Competencies
- Fluent in local language(s) and English (verbal/written); strong communication.
- Working knowledge of clinical research/clinical trial phases and GCP/ICH + country regulations.
- Good documentation practices; site management/monitoring; independent judgment.
- Strong IT skills and ability to analyze data/metrics; root cause analysis with corrective/preventive action.
Education/Experience
- Associate’s (science/healthcare) + 5+ years relevant healthcare experience, including 2+ years direct site management/monitoring in bio/pharma/CRO; OR Bachelor’s (or above) + 2+ years direct site management/monitoring.
Required Skills
- Adverse Event Reporting System; Clinical Research Methods; Clinical Site/Study Management; Clinical Trials/Monitoring; Preventive Action; Protocol Adherence; Regulatory Affairs/Compliance; Site Management.
Application
- Apply via https://jobs.merck.com/us/en (deadline stated on posting).
- Accountable for performance and compliance for assigned protocols and sites; ensures study conduct complies with ICH/GCP and country regulations, company policies/procedures, quality standards, and adverse event reporting requirements.
- Primary site contact and site manager across all phases of clinical research studies.
- Develop and expand territory by finding and developing new sites.
- Participate in internal meetings/workstreams as SME for monitoring processes/systems.
Responsibilities
- Develop strong site relationships and ensure continuity throughout the trial.
- Perform site management/monitoring activities per ICH-GCP, sponsor SOPs, local laws, protocol, site monitoring plan.
- Understand study protocol and procedures; coordinate tasks to achieve “Site Ready.”
- Contribute to site selection/validation.
- Conduct remote and on-site monitoring/oversight to ensure data integrity, subject rights/safety/well-being.
- Conduct validation, initiation, monitoring, close-out visits; ensure timely, accurate visit and non-visit reports.
- Collect/review/monitor required regulatory documentation (start-up, maintenance, close-out).
- Communicate with investigators/site staff on protocol conduct, recruitment/retention, deviations, regulatory documentation, audits/inspections, site performance.
- Identify/escalate and resolve site performance/quality/compliance problems via CRA escalation pathway.
- Partner with internal functions and external stakeholders (vendors, IRB/IECs, regulatory authorities).
- Maintain documentation in CTMS/eTMF and systems per timelines; act as SME/buddy/mentor.
- Support/lead audits/inspections; perform co-monitoring when appropriate.
Travel: Approx. 65–75% (about 2–3 days/week). Current driver’s license required.
Core Competencies
- Fluent in local language(s) and English (verbal/written); strong communication.
- Working knowledge of clinical research/clinical trial phases and GCP/ICH + country regulations.
- Good documentation practices; site management/monitoring; independent judgment.
- Strong IT skills and ability to analyze data/metrics; root cause analysis with corrective/preventive action.
Education/Experience
- Associate’s (science/healthcare) + 5+ years relevant healthcare experience, including 2+ years direct site management/monitoring in bio/pharma/CRO; OR Bachelor’s (or above) + 2+ years direct site management/monitoring.
Required Skills
- Adverse Event Reporting System; Clinical Research Methods; Clinical Site/Study Management; Clinical Trials/Monitoring; Preventive Action; Protocol Adherence; Regulatory Affairs/Compliance; Site Management.
Application
- Apply via https://jobs.merck.com/us/en (deadline stated on posting).