Clinical Research Associate – Site Director

Job not on LinkedIn

🔥 44 minutes ago

🇦🇷 Argentina – Remote

⏰ Full Time

🔴 Lead

🧪 Clinical Research

👻 Ghost score 12%

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Logo of Codera

Codera

11 - 50 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Codera is a B2B company that partners with biotechnology and pharmaceutical companies to provide end-to-end drug development expertise and infrastructure. It supports clients across the drug development lifecycle with technical, operational, and infrastructure services to help advance therapeutic programs.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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

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