Cra Ii - Sponsor Dedicated - Chile Home Based

0-2 years

Not Disclosed

Remote

10 Oct. 10, 2025

Job Description

Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

Clinical Research Associate II (CRA II) – Sponsor Dedicated

Location:

Chile – Home-Based (Remote)

Job ID:

25102446
Updated: Yesterday

About Syneos Health®

Syneos Health is a global, fully integrated biopharmaceutical solutions organization designed to accelerate customer success by connecting clinical, medical affairs, and commercial expertise.

With 29,000 employees across 110 countries, we place the customer and patient at the center of everything we do. Our model streamlines operations to make Syneos Health easier to work with — and for.

WORK HERE MATTERS EVERYWHERE

Why Join Syneos Health

🌱 Career Development & Progression: Strong support for growth through technical and therapeutic training.
🤝 Supportive Leadership: Engaged managers who value collaboration and recognition.
🌍 Inclusive Culture: “Total Self” philosophy encourages authenticity, diversity, and belonging.
💡 Continuous Improvement: A culture of innovation and problem-solving to improve trial outcomes and workplace experience.

Key Responsibilities

Clinical Monitoring & Site Management

Conduct site qualification, initiation, monitoring, and close-out visits (on-site or remote).
Ensure compliance with ICH-GCP, GPP, local regulations, and study protocols.
Evaluate site and investigator performance, identify issues, and develop corrective action plans.
Verify informed consent documentation and uphold patient confidentiality.
Identify and manage protocol deviations, safety issues, and pharmacovigilance concerns.

Data Quality & Documentation

Review source documents and medical records for accuracy and completeness.
Verify case report form (CRF) data and resolve queries promptly.
Ensure compliance with electronic data capture (EDC) requirements.
Maintain accurate ISF/TMF reconciliation and ensure regulatory archiving standards.
Document activities in trip reports, follow-up letters, communication logs, and other study documents.

Investigational Product (IP) Oversight

Perform IP inventory and reconciliation; review storage and security.
Verify correct dispensing and administration per protocol.
Ensure proper labeling, importation, and return procedures align with GCP/local regulations.

Project & Site Coordination

Manage site-level communication, deliverables, and timelines per project scope.
Support subject recruitment and retention initiatives.
Act as the primary site liaison or collaborate with Central Monitoring Associates.
Prepare for and attend investigator meetings, sponsor meetings, and training sessions.
Maintain audit readiness and assist with inspection follow-ups.

Additional Responsibilities (Real World Late Phase Studies)

Support sites from identification to close-out.
Conduct chart abstraction and data collection.
Collaborate with sponsor affiliates, medical science liaisons, and local teams.
Recommend potential study sites based on local treatment patterns and investigator networks.
Identify out-of-scope activities and escalate to project leads.
Train and mentor junior staff as needed.

Qualifications

Requirement	Details
Education	Bachelor’s degree in a related field or RN qualification, or equivalent experience.
Knowledge	Strong understanding of ICH-GCP guidelines, local regulatory requirements, and clinical trial operations.
Technical Skills	Proficient in Microsoft Office, clinical trial software, and EDC systems; open to learning new technologies.
Soft Skills	Excellent communication, presentation, and interpersonal skills.
Travel	Willingness to travel up to 75% regularly.
Other (U.S. Sites)	Must comply with any site-specific health and access requirements.

Role Summary

CRAs within Clinical Monitoring are responsible for ensuring the integrity, quality, and compliance of clinical research studies.
They conduct both on-site and remote monitoring, verify protocol adherence, and leverage risk-based monitoring tools and data analytics to identify trends and maintain study quality.

Impact & Contribution

Serves as an individual contributor or may lead small components of projects.
Responsible for implementing and optimizing monitoring processes and study operations.
Uses clinical knowledge and analytical skills to maintain data accuracy and patient safety.

About Syneos Health (Quick Facts)

Supported 94% of FDA-approved drugs and 95% of EMA-authorized products in the past 5 years.
Managed 200+ clinical studies across 73,000 sites with 675,000+ trial patients globally.

🔗 Visit: www.syneoshealth.com

Equal Opportunity Commitment

Syneos Health is committed to diversity and inclusion. Applicants with diverse backgrounds or transferable skills are encouraged to apply.
We comply with the Americans with Disabilities Act (ADA) and provide reasonable accommodations for applicants and employees.

Position Overview Summary

Category	Details
Job Title	Clinical Research Associate II (Sponsor Dedicated)
Location	Chile – Home-Based
Work Type	Remote
Employer	Syneos Health
Function	Clinical Monitoring / Site Management
Travel Requirement	Up to 75%
Key Skills	GCP, Clinical Monitoring, Data Verification, Audit Readiness, EDC Systems
Website	www.syneoshealth.com

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Cra Ii - Sponsor Dedicated - Chile Home Based

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