Clinical Research Associate - Global Site Monitoring

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/work streams.
• 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; escalation 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.

• 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.

• 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.

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