Clinical Research Associate (CRA) - Cardiovascular (Remote)
Merck
August 26, 2026
Remote friendly (Miami, FL)
United States
Clinical Research and Development
Candidate must reside in South Florida (Ft. Lauderdale, Miami, Boca Raton, Key Largo) and be fluent in Spanish.
Responsibilities:
- Ensure compliance for assigned protocols/sites with ICH-GCP, country regulations, sponsor policies/SOPs, quality standards, and adverse event reporting.
- Act as primary site contact/site manager across all phases of clinical studies; take overall responsibility for allocated sites.
- Develop and expand territory by finding and developing new sites.
- Perform remote and on-site monitoring/oversight to ensure complete/accurate/unbiased data and protection of subjects’ rights, safety, and well-being.
- Conduct validation, initiation, monitoring, and close-out visits; ensure timely, accurate visit/non-visit reports.
- Collect, review, and monitor regulatory documentation for study start-up/maintenance/close-out.
- Communicate with investigators and site staff on protocol conduct, recruitment/retention, deviations, documentation, audits/inspections, and site performance.
- Identify/escalate and resolve quality/compliance issues per CRA escalation pathway; partner with internal/external stakeholders (GCTO, finance, regulatory, PV, legal, IRBs/IECs, Regulatory Authorities).
- Manage CTMS/eTMF documentation; support audit/inspection and co-monitoring visits; contribute as SME/mentor.
Qualifications:
- Fluent in Spanish and English (verbal/written); strong technical communication.
- Working knowledge of clinical research phases and GCP/ICH and country clinical research laws/guidelines.
- Good Documentation Practices; strong site management (including patient recruitment); independent monitoring judgment.
- Good IT skills; ability to analyze data/metrics and perform root cause analysis with corrective/preventive actions.
Experience/Education:
- Associate degree + 5+ years healthcare experience, including 2+ years direct site management (bio/pharma/CRO), or
- Bachelor’s (or above) + 2+ years direct site management.
Skills:
- Clinical Trials Monitoring, Protocol Adherence, Regulatory Compliance, Pharmacovigilance, Adverse Event Reporting Systems, Data Analysis/Reporting, Preventive Action.
Extent of Travel: 65%-75% (~2–3 days/week). Current driver’s license required.
Benefits (if applicable): medical/dental/vision, insurance, retirement (401(k)), paid holidays, vacation, compassionate and sick days.
Application: Apply via https://jobs.merck.com/us/en (deadline listed on posting).
Responsibilities:
- Ensure compliance for assigned protocols/sites with ICH-GCP, country regulations, sponsor policies/SOPs, quality standards, and adverse event reporting.
- Act as primary site contact/site manager across all phases of clinical studies; take overall responsibility for allocated sites.
- Develop and expand territory by finding and developing new sites.
- Perform remote and on-site monitoring/oversight to ensure complete/accurate/unbiased data and protection of subjects’ rights, safety, and well-being.
- Conduct validation, initiation, monitoring, and close-out visits; ensure timely, accurate visit/non-visit reports.
- Collect, review, and monitor regulatory documentation for study start-up/maintenance/close-out.
- Communicate with investigators and site staff on protocol conduct, recruitment/retention, deviations, documentation, audits/inspections, and site performance.
- Identify/escalate and resolve quality/compliance issues per CRA escalation pathway; partner with internal/external stakeholders (GCTO, finance, regulatory, PV, legal, IRBs/IECs, Regulatory Authorities).
- Manage CTMS/eTMF documentation; support audit/inspection and co-monitoring visits; contribute as SME/mentor.
Qualifications:
- Fluent in Spanish and English (verbal/written); strong technical communication.
- Working knowledge of clinical research phases and GCP/ICH and country clinical research laws/guidelines.
- Good Documentation Practices; strong site management (including patient recruitment); independent monitoring judgment.
- Good IT skills; ability to analyze data/metrics and perform root cause analysis with corrective/preventive actions.
Experience/Education:
- Associate degree + 5+ years healthcare experience, including 2+ years direct site management (bio/pharma/CRO), or
- Bachelor’s (or above) + 2+ years direct site management.
Skills:
- Clinical Trials Monitoring, Protocol Adherence, Regulatory Compliance, Pharmacovigilance, Adverse Event Reporting Systems, Data Analysis/Reporting, Preventive Action.
Extent of Travel: 65%-75% (~2–3 days/week). Current driver’s license required.
Benefits (if applicable): medical/dental/vision, insurance, retirement (401(k)), paid holidays, vacation, compassionate and sick days.
Application: Apply via https://jobs.merck.com/us/en (deadline listed on posting).