Clinical Research Associate – Site Director

This is a fully remote position, open to applicants in Argentina.

📋 Description

• Oversee clinical sites for Phase I–IV trials from initiation through to closure.

• Conduct site identification, feasibility studies, pre-study evaluations, study initiation, monitoring, patient recruitment, and closure activities.

• Ensure clinical site management and monitoring adheres to ICH-GCP, SOPs, local regulations, and study protocols.

• Act as the primary liaison for clinical sites throughout all phases of the study.

• Organize monitoring availability and uphold data entry timelines.

• Execute source data verification, remote data reviews, and resolve queries.

• Create site-specific plans for recruitment, retention, and follow-up.

• Engage with investigators and site personnel regarding protocol execution, recruitment, deviations, inspection preparedness, and site performance.

• Identify, evaluate, escalate, and resolve issues related to site performance and quality.

• Assemble and gather essential documents for regulatory and IRB/EC submissions.

• Facilitate negotiations for site budgets and contracts, finalizing clinical trial agreements.

• Support investigator site audits and inspection processes.

• Share best practices and participate in initiatives aimed at enhancing clinical operations.

• Provide coaching and mentoring to colleagues.

• Review systems and procedures while assisting with study management and staff training as required.

⛳️ Requirements

• A Bachelor’s Degree in a Life Science discipline is mandatory.

• A Bachelor’s degree in nursing or being a Registered Nurse is a plus.

• At least 3 years of direct site monitoring experience is essential.

• Advanced English proficiency or a professional level of working English is required.

• Comprehensive understanding of clinical site monitoring and the overall drug development process.

• In-depth knowledge of FDA, ICH, and GCP guidelines, along with relevant local regulations.

• Capability to comprehend complex patient histories, medical terminology, and treatment landscapes.

• Ability to analyze study-level metrics and proactively identify and mitigate potential risks.

• Detail-oriented, organized, and dedicated to maintaining quality and consistency.

• Proven track record of managing competing high-priority assignments and meeting deliverables within set timelines.

• Strong team interaction skills.

• Ability to thrive in a dynamic environment and demonstrate flexibility.

• Capacity to contribute to process improvement initiatives.

• Outstanding written and verbal communication skills.

• Experience and proven competence in CTMS and eTMF systems is preferred.

• Willingness and ability to travel up to 50–65% of the time.

• Candidates located in Argentina are preferred; proximity to a major airport and flexibility for multi-day travel are essential.

🏝️ Benefits

• This position may qualify for discretionary bonuses and other incentive programs.

• Employer-sponsored medical, dental, and vision insurance plans.

• Generous paid time off policy.

• Options for retirement planning.

• Wellness programs available.

• Opportunities for professional development.