Sr Clinical Research Associate (Sr CRA) – Ophthalmology -Remote
Merck
September 03, 2026
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
Role: Accountable for performance and compliance for assigned protocols and sites in a country. Ensures study conduct complies with ICH/GCP, country regulations, sponsor policies/procedures, quality standards, and adverse event reporting.
Responsibilities:
- Act as primary site contact/site manager through all study phases; maintain site relationships.
- Perform site management/monitoring (remote and on-site) per ICH-GCP, Sponsor SOPs, local laws, protocol, and Site Monitoring Plan; ensure data integrity and subject rights/safety/well-being.
- Conduct validation/initiation/monitoring/close-out visits; ensure timely, accurate reports.
- Collect/review/monitor regulatory documentation for study start-up, maintenance, and close-out.
- Communicate with investigators/site staff on protocol conduct, recruitment/retention, deviations, regulatory docs, audits/inspections, and site performance.
- Identify, assess, resolve quality/compliance issues; escalate via CRA Escalation Pathway as needed.
- Manage documentation in CTMS/eTMF and other systems.
- Serve as SME for monitoring processes; share best practices, recommend improvements, and provide training.
- Support/lead audits/inspections; contribute to new site identification and development.
- Mentor/buddy junior CRAs; perform co-monitoring visits (and possibly QC visits if delegated/trained).
Travel: ~65–75% working time (~2–3 days/week). Current driver’s license preferred (may be required).
Qualifications/Experience:
- 5 years ophthalmology experience required (retina preferred).
- Associate’s degree/certificate in scientific/healthcare + at least 7 years relevant healthcare experience, including ≥4 years direct site management (bio/pharma/CRO); OR Bachelor’s (or above) + ≥4 years direct site management.
Core/Required Skills (selected): ICH-GCP/GCP knowledge; strong site management/monitoring; good documentation practices; ability to analyze metrics/data; IT skills; demonstrated mentoring/leadership.
Preferred Skills: Clinical research/trials experience; on-site monitoring.
Benefits (as stated): Eligible for annual bonus/long-term incentive (if applicable); comprehensive benefits package (medical/dental/vision, retirement/401(k), paid holidays/vacation, and compassionate/sick days).
Application: Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if internal). Apply by the deadline shown on the posting.
Responsibilities:
- Act as primary site contact/site manager through all study phases; maintain site relationships.
- Perform site management/monitoring (remote and on-site) per ICH-GCP, Sponsor SOPs, local laws, protocol, and Site Monitoring Plan; ensure data integrity and subject rights/safety/well-being.
- Conduct validation/initiation/monitoring/close-out visits; ensure timely, accurate reports.
- Collect/review/monitor regulatory documentation for study start-up, maintenance, and close-out.
- Communicate with investigators/site staff on protocol conduct, recruitment/retention, deviations, regulatory docs, audits/inspections, and site performance.
- Identify, assess, resolve quality/compliance issues; escalate via CRA Escalation Pathway as needed.
- Manage documentation in CTMS/eTMF and other systems.
- Serve as SME for monitoring processes; share best practices, recommend improvements, and provide training.
- Support/lead audits/inspections; contribute to new site identification and development.
- Mentor/buddy junior CRAs; perform co-monitoring visits (and possibly QC visits if delegated/trained).
Travel: ~65–75% working time (~2–3 days/week). Current driver’s license preferred (may be required).
Qualifications/Experience:
- 5 years ophthalmology experience required (retina preferred).
- Associate’s degree/certificate in scientific/healthcare + at least 7 years relevant healthcare experience, including ≥4 years direct site management (bio/pharma/CRO); OR Bachelor’s (or above) + ≥4 years direct site management.
Core/Required Skills (selected): ICH-GCP/GCP knowledge; strong site management/monitoring; good documentation practices; ability to analyze metrics/data; IT skills; demonstrated mentoring/leadership.
Preferred Skills: Clinical research/trials experience; on-site monitoring.
Benefits (as stated): Eligible for annual bonus/long-term incentive (if applicable); comprehensive benefits package (medical/dental/vision, retirement/401(k), paid holidays/vacation, and compassionate/sick days).
Application: Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if internal). Apply by the deadline shown on the posting.