Clinical Research Associate (CRA) - Cardiovascular (Remote)

Responsibilities:
- Accountable for performance and compliance for assigned protocols and sites.
- Ensure study conduct complies with ICH/GCP, country regulations, company policies, quality standards, and adverse event reporting requirements.
- Act as primary site contact/site manager across all phases of a clinical research study for assigned sites.
- Develop/expand territory by finding and developing new sites.
- Serve as SME for monitoring processes and systems in internal meetings/workstreams.
- Build strong site relationships and ensure continuity through the trial.
- Perform site management/monitoring activities per ICH-GCP, Sponsor SOPs, local laws, protocol, Site Monitoring Plan.
- Gain in-depth understanding of the protocol and procedures.
- Collaborate to achieve “Site Ready”; provide input on site selection/validation.
- Conduct remote/on-site monitoring to ensure data integrity and protection of subjects’ rights, safety, and well-being.
- Conduct visits (validation, initiation, monitoring, close-out) and complete timely visit/non-visit contact reports.
- Collect/review/monitor regulatory documentation for start-up, maintenance, and close-out.
- Communicate with investigators/site staff on protocol conduct, recruitment/retention, deviations, regulatory documentation, audits/inspections, and site performance.
- Identify and resolve site quality/compliance issues; escalate per CRA Escalation Pathway as needed.
- Support assigned sites with cross-functional partners (ops, finance, regulatory, PV, legal, HQ) and external stakeholders (vendors, IRBs/IECs, authorities).
- Maintain documentation in CTMS/eTMF and other systems per timelines.
- Act as CRA process SME/buddy/mentor; support/lead audits/inspections; perform co-monitoring.
- Support identification and development of new potential sites per country strategy.

Qualifications/Requirements:
- Fluent in Spanish and English (verbal/written) with excellent communication of technical information.
- Good knowledge of clinical research, trial phases, GCP/ICH, and country clinical research laws/guidelines.
- Hands-on knowledge of Good Documentation Practices.
- Proven site management skills (including patient recruitment) and high-level independent monitoring judgment.
- Strong IT skills; ability to analyze data/metrics; solution-oriented mindset; perform root cause analysis and corrective/preventive actions.
- Effective time management/organizational skills; conflict management/problem-solving; ability to work independently across multiple protocols/sites/therapy areas; culturally sensitive in a matrix multicultural environment.
- Education/experience: Associate’s degree (or equivalent) + 5+ years healthcare experience, including 2+ years direct site management/monitoring in bio/pharma/CRO; OR Bachelor’s degree (or above) + 2+ years direct site management/monitoring.
- Current driver’s license required.

Skills (required):
- Adaptability; Adverse Event Reporting Systems; Clinical Research Methods; Clinical Site Management; Clinical Study Management; Clinical Trial Planning; Clinical Trials Monitoring; Data Analysis/Reporting; Good Clinical Data Management Practice (GCDMP); Pharmacovigilance; Preventive Action; Protocol Adherence; Regulatory Affairs/Compliance; Site Management.

Travel:
- Domestic/international travel ~65–75% (~2–3 days/week).

Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee).