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CRA II or Sr CRA Sponsor Dedicated (Argentina - Home-based)

Description

This position is a dedicated Clinical Research Associate located in Argentina, eligible for home-based work. The role supports site qualification, monitoring, and close-out activities, ensuring regulatory and protocol compliance.

Job Responsibilities

- Perform site qualification, site initiation, interim monitoring, site management, and close-out visits (on-site or remotely) ensuring regulatory, ICH-GCP and Good Pharmacoepidemiology Practices and protocol compliance.
- Verify that informed consent has been appropriately obtained and documented; protect patient confidentiality.
- Assess site processes, conduct source document review, and verify accurate completion of case report forms.
- Apply query resolution techniques, driving resolution to closure within agreed timelines.
- Use hardware and software for clinical data review; verify compliance with electronic data capture requirements.
- Perform investigational product inventory and reconciliation; ensure dispensing and administration according to protocol.
- Review Investigator Site File for accuracy and timeliness, reconciling with Trial Master File.
- Document activities through letters, trip reports, and logs as required by SOPs and the Clinical Monitoring Plan.
- Manage site-level activities, ensuring project objectives, deliverables, and timelines are met.
- Act as primary liaison with study site personnel,



ensuring training and compliance with requirements.
- Prepare for and attend investigator and sponsor meetings; participate in clinical training sessions.
- Support audit readiness and preparation, including follow-up actions.
- Mentor junior CRAs and provide training and sign-off visits as assigned.
- For Real World Late Phase studies, support site lifecycle activities, data collection, and regulatory updates.

Qualifications

- Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
- Knowledge of Good Clinical Practice/ICH Guidelines and other regulatory requirements.
- Strong computer skills with the ability to embrace new technologies.
- Excellent communication, presentation, and interpersonal skills; critical thinking.
- Ability to travel up to 75% of the time.

Additional Information

Tasks, duties, and responsibilities are not exhaustive. The Company may assign other tasks at its discretion and determine equivalent qualifications. The Company complies with laws governing equal opportunity employment and the Americans with Disabilities Act, providing reasonable accommodations.

Summary

The role requires a Clinical Research Associate with expertise in site management, monitoring, and compliance, contributing to integral clinical studies and ensuring data integrity and patient safety.

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Postúlate en Kit Empleo: kitempleo.com.ar/empleo/q06q0

📌 CRA II or Sr CRA Sponsor Dedicated (Argentina - Home-based) (Buenos Aires)
🏢 Syneos Health
📍 Buenos Aires