Clinical Research Associate – Site Director

• Manage clinical sites for Phase I–IV studies from start-up through close-out
• Perform site identification, feasibility, pre-study evaluation, study start-up, site initiation, monitoring, patient recruitment and close-out activities
• Conduct clinical site management and monitoring in compliance with ICH-GCP, SOPs, local laws, regulations and study protocols
• Serve as primary contact for clinical sites throughout all study phases
• Arrange monitoring availability and maintain data-entry timelines
• Perform source data verification, remote data review and query resolution
• Develop site-specific recruitment, retention and follow-up plans
• Communicate with investigators and site staff regarding protocol conduct, recruitment, deviations, inspection readiness and site performance
• Identify, assess, escalate and resolve site performance and quality issues
• Prepare and collect essential documents for regulatory and IRB/EC submissions
• Facilitate site budget and contract negotiations and finalize clinical trial agreements
• Support investigator site audits and inspection activities
• Contribute best practices and participate in clinical operations improvement initiatives
• Coach and mentor colleagues
• Review systems and procedures and support study management and staff training as needed

• Bachelor’s Degree in a Life Science discipline required
• Bachelor’s degree in nursing or RN a plus
• Minimum 3 years of direct site monitoring experience required
• Advanced English proficiency or professional working proficiency in English required
• Detailed understanding of clinical site monitoring and overall drug development
• Thorough understanding of FDA, ICH and GCP guidelines and applicable local regulations
• Ability to understand complex patient histories, medical terminology and treatment landscapes
• Ability to interpret study-level metrics and proactively identify and mitigate risks
• Detail-oriented, organized and committed to quality and consistency
• Proven ability to manage competing high-priority assignments and achieve deliverables within specified timelines
• Excellent team-interaction skills
• Ability to work in a dynamic environment with flexibility
• Ability to contribute to process improvement initiatives
• Excellent written and verbal communication skills
• Experience and proven proficiency in CTMS and eTMF systems preferred
• Willingness and ability to travel up to 50–65%
• Candidates based in Argentina are preferred; proximity to a major airport and flexibility for multi-day travel are essential

• This role may be eligible for discretionary bonuses and other incentive programs.
• Employer-sponsored medical, dental and vision insurance plans
• Generous paid time off
• Retirement plan options
• Wellness programs
• Professional development programs