Clinical Research Associate (CRA) - Cardiovascular (Remote)
Merck
August 25, 2026
Remote friendly (Miami Beach, FL)
United States
Clinical Research and Development
Location/Language: Candidate must reside in South Florida (Ft. Lauderdale, Miami, Boca Raton, Key Largo) and be fluent in Spanish.
Responsibilities:
- Ensure performance and compliance for assigned protocols/sites; oversee study conduct in line with ICH/GCP, country regulations, company policies, quality standards, and adverse event reporting.
- Act as primary site contact/site manager across all trial phases; manage allocated sites.
- Develop and expand territory by finding and developing new sites.
- Serve as SME for monitoring processes/systems in internal workstreams.
- Build and maintain site relationships; coordinate tasks to achieve “Site Ready.”
- Perform remote and on-site monitoring to ensure data integrity and protection of subjects’ rights, safety, and well-being.
- Conduct validation/initiation/monitoring/close-out visits; ensure timely, accurate visit and contact reports.
- Collect/review/monitor regulatory documentation for start-up, maintenance, and close-out.
- Communicate with site staff on protocol conduct, recruitment/retention, deviations, documentation, audits/inspections, and site performance.
- Resolve site quality/compliance issues and escalate via CRA Escalation Pathway as needed.
- Manage documentation in CTMS/eTMF and support CTMS/eTMF timelines.
- Support/lead audits/inspections; perform co-monitoring when appropriate.
Qualifications/Requirements:
- Fluent Spanish & English (verbal/written); strong communication.
- Working knowledge of clinical research phases and GCP/ICH and country regulations.
- Hands-on Good Documentation Practices; IT skills; data/metrics analysis ability.
- Root cause analysis and preventive/corrective action.
- Experience: Associate’s degree in scientific/healthcare field + 5+ years relevant experience including 2+ years direct site management (bio/pharma/CRO), OR Bachelor’s degree + 2+ years.
- Travel ~65–75% (about 2–3 days/week); current driver’s license required.
Required skills (examples): Clinical Site Management, Clinical Trial Monitoring, Protocol Adherence, Regulatory Compliance, Pharmacovigilance, Clinical Trials/Data Analysis.
Benefits (as stated): Eligible for annual bonus and long-term incentive (if applicable) and comprehensive benefits package (medical/dental/vision, retirement/401(k), paid holidays, vacation, and sick days).
Application: Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is stated on the posting.
Responsibilities:
- Ensure performance and compliance for assigned protocols/sites; oversee study conduct in line with ICH/GCP, country regulations, company policies, quality standards, and adverse event reporting.
- Act as primary site contact/site manager across all trial phases; manage allocated sites.
- Develop and expand territory by finding and developing new sites.
- Serve as SME for monitoring processes/systems in internal workstreams.
- Build and maintain site relationships; coordinate tasks to achieve “Site Ready.”
- Perform remote and on-site monitoring to ensure data integrity and protection of subjects’ rights, safety, and well-being.
- Conduct validation/initiation/monitoring/close-out visits; ensure timely, accurate visit and contact reports.
- Collect/review/monitor regulatory documentation for start-up, maintenance, and close-out.
- Communicate with site staff on protocol conduct, recruitment/retention, deviations, documentation, audits/inspections, and site performance.
- Resolve site quality/compliance issues and escalate via CRA Escalation Pathway as needed.
- Manage documentation in CTMS/eTMF and support CTMS/eTMF timelines.
- Support/lead audits/inspections; perform co-monitoring when appropriate.
Qualifications/Requirements:
- Fluent Spanish & English (verbal/written); strong communication.
- Working knowledge of clinical research phases and GCP/ICH and country regulations.
- Hands-on Good Documentation Practices; IT skills; data/metrics analysis ability.
- Root cause analysis and preventive/corrective action.
- Experience: Associate’s degree in scientific/healthcare field + 5+ years relevant experience including 2+ years direct site management (bio/pharma/CRO), OR Bachelor’s degree + 2+ years.
- Travel ~65–75% (about 2–3 days/week); current driver’s license required.
Required skills (examples): Clinical Site Management, Clinical Trial Monitoring, Protocol Adherence, Regulatory Compliance, Pharmacovigilance, Clinical Trials/Data Analysis.
Benefits (as stated): Eligible for annual bonus and long-term incentive (if applicable) and comprehensive benefits package (medical/dental/vision, retirement/401(k), paid holidays, vacation, and sick days).
Application: Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is stated on the posting.