Clinical Research Associate – Site Director

Codera

. Manage clinical sites for Phase I–IV studies from start-up through close-out .

Posted 10/14/2026full-timeRemote • ArgentinaLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical site management and monitoring, ensuring compliance with ICH-GCP, FDA guidelines, and local regulations. Proficient in patient recruitment strategies, data verification, and regulatory submissions while maintaining high-quality standards and effective communication with site staff.

Highest-signal resume keywords

Clinical Site ManagementSite Monitoring ExperienceICH-GCP ComplianceRegulatory SubmissionsCTMS and eTMF Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Site MonitoringPatient RecruitmentSource Data VerificationStudy Protocol ComplianceRisk MitigationData Entry ManagementBudget NegotiationContract FinalizationProcess ImprovementMedical Terminology

Soft Skills

Detail-OrientedOrganizedTeam InteractionFlexibilityCommunication Skills

Tools & Technologies

CTMSETMF

Certifications & Qualifications

Bachelor’s Degree in Life ScienceRN (Registered Nurse) Preferred

Industry Keywords

Clinical TrialsPhase I–IV StudiesFDA GuidelinesICH GuidelinesGCP GuidelinesIRB/EC SubmissionsSite PerformanceQuality AssuranceClinical OperationsPatient Histories

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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