Clinical Research Associate (CRA) - Oncology (Remote)
Merck
August 26, 2026
Remote friendly (Mobile, AL)
United States
Clinical Research and Development
Candidate must reside in: Alabama, Georgia, Colorado, Massachusetts, Michigan, Maryland, Pennsylvania.
The role ensures performance and compliance for assigned protocols/sites in a country under the oversight of the CRA-Manager.
Responsibilities (including but not limited to):
- Act as primary site contact and site manager across all study phases; manage allocated sites and maintain site relationships.
- Conduct clinical site management/monitoring in compliance with ICH-GCP, Sponsor SOPs, local laws, protocol, Site Monitoring Plan.
- Perform remote and on-site monitoring/oversight to ensure data integrity and subject rights, safety, and well-being.
- Conduct visit types (validation, initiation, monitoring, close-out) and ensure accurate timely 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, documentation, audits/inspections, and site performance.
- Identify/resolve site quality/compliance issues and escalate per CRA Escalation Pathway as needed.
- Manage documentation in CTMS/eTMF and other systems; support/lead audits/inspections; perform co-monitoring.
- Contribute to site selection/validation and expand territory by identifying/developing new sites.
Extent of Travel:
- ~65–75% travel (~2–3 days/week). Valid driver’s license required.
Core competency expectations:
- Fluent local language(s) and English (verbal/written); strong communication; GCP/ICH and country clinical research law knowledge; good documentation practices; IT skills; independent monitoring judgment; data/metrics analysis; root cause analysis and corrective/preventive actions.
Behavioral expectations:
- Time management, organization, problem solving; independent work across protocols/sites; accountability/urgency; culturally sensitive collaboration; customer focus; quality/compliance mindset.
Experience/Education:
- Associate degree/certificate (scientific/healthcare) + 5+ years relevant experience, including 2+ years direct site management/monitoring in bio/pharma/CRO; OR Bachelor’s (or above) + 2+ years direct site management/monitoring.
Skills (required): Accountability; Clinical Site Management/Monitoring; Clinical Study Management; Clinical Trial Planning; Data Analysis/Reporting; GCP; Good Documentation Practices/GCDMP; IT; Preventive/Corrective Action; Protocol Adherence; Regulatory Compliance; Pharmacovigilance.
Preferred skills:
- Not specified.
Compensation/Benefits (if applicable as stated): Annual bonus and long-term incentive (if applicable); comprehensive benefits (medical/dental/vision, retirement/401(k), paid holidays/vacation, compassionate and sick days).
Salary range: $96,200.00–$151,400.00.
Application instructions:
- Apply at https://jobs.merck.com/us/en (or via Workday Jobs Hub if current employee). Application deadline listed on posting. Requisition ID: R406342.
The role ensures performance and compliance for assigned protocols/sites in a country under the oversight of the CRA-Manager.
Responsibilities (including but not limited to):
- Act as primary site contact and site manager across all study phases; manage allocated sites and maintain site relationships.
- Conduct clinical site management/monitoring in compliance with ICH-GCP, Sponsor SOPs, local laws, protocol, Site Monitoring Plan.
- Perform remote and on-site monitoring/oversight to ensure data integrity and subject rights, safety, and well-being.
- Conduct visit types (validation, initiation, monitoring, close-out) and ensure accurate timely 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, documentation, audits/inspections, and site performance.
- Identify/resolve site quality/compliance issues and escalate per CRA Escalation Pathway as needed.
- Manage documentation in CTMS/eTMF and other systems; support/lead audits/inspections; perform co-monitoring.
- Contribute to site selection/validation and expand territory by identifying/developing new sites.
Extent of Travel:
- ~65–75% travel (~2–3 days/week). Valid driver’s license required.
Core competency expectations:
- Fluent local language(s) and English (verbal/written); strong communication; GCP/ICH and country clinical research law knowledge; good documentation practices; IT skills; independent monitoring judgment; data/metrics analysis; root cause analysis and corrective/preventive actions.
Behavioral expectations:
- Time management, organization, problem solving; independent work across protocols/sites; accountability/urgency; culturally sensitive collaboration; customer focus; quality/compliance mindset.
Experience/Education:
- Associate degree/certificate (scientific/healthcare) + 5+ years relevant experience, including 2+ years direct site management/monitoring in bio/pharma/CRO; OR Bachelor’s (or above) + 2+ years direct site management/monitoring.
Skills (required): Accountability; Clinical Site Management/Monitoring; Clinical Study Management; Clinical Trial Planning; Data Analysis/Reporting; GCP; Good Documentation Practices/GCDMP; IT; Preventive/Corrective Action; Protocol Adherence; Regulatory Compliance; Pharmacovigilance.
Preferred skills:
- Not specified.
Compensation/Benefits (if applicable as stated): Annual bonus and long-term incentive (if applicable); comprehensive benefits (medical/dental/vision, retirement/401(k), paid holidays/vacation, compassionate and sick days).
Salary range: $96,200.00–$151,400.00.
Application instructions:
- Apply at https://jobs.merck.com/us/en (or via Workday Jobs Hub if current employee). Application deadline listed on posting. Requisition ID: R406342.