Job Title:
CRA II – Sponsor Dedicated (Home-Based, Chile)
Location: Chile (Remote)
Company: Syneos Health®
Job ID: 25102446
Updated: Yesterday
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization designed to accelerate customer success. The company combines clinical, medical affairs, and commercial insights to deliver outcomes that address modern healthcare challenges.
Key Highlights:
29,000 employees across 110 countries
Collaborated on 94% of FDA-approved novel drugs in the past 5 years
Supported over 200 studies across 73,000 sites and 675,000+ patients
Our Mission:
To simplify and streamline clinical research processes — making Syneos Health easier to work with and easier to work for.
Our Culture – “Total Self”
A global culture that promotes authenticity, diversity, inclusivity, and employee well-being. We believe that when employees can be their true selves, innovation and collaboration thrive.
Why Work at Syneos Health
Career development and progression opportunities
Technical and therapeutic area training
Supportive and engaged management team
Peer recognition and rewards programs
Inclusive “Total Self” work culture that values belonging and well-being
Role Overview
The Clinical Research Associate II (CRA II) plays a vital role in ensuring the integrity and quality of clinical trials through effective site management and monitoring activities. This position involves working remotely while overseeing sites across Chile, ensuring compliance with ICH-GCP guidelines, regulatory requirements, and sponsor protocols.
Key Responsibilities
1. Site Management & Monitoring
Conduct site qualification, initiation, interim monitoring, and close-out visits (on-site or remote).
Evaluate site and staff performance; provide recommendations and escalate serious issues.
Ensure protocol, ICH-GCP, and regulatory compliance.
2. Patient Safety & Data Integrity
Verify informed consent documentation for all participants.
Monitor protocol deviations, violations, and pharmacovigilance issues.
Perform source document verification and CRF data checks.
Use electronic data capture systems effectively for data review and resolution.
3. Investigational Product (IP) Oversight
Manage IP inventory, reconciliation, and storage security.
Confirm proper dispensing and administration according to protocol.
Ensure compliance with labeling, import/export, release, and return procedures.
4. Documentation & Reporting
Maintain and reconcile the Investigator Site File (ISF) and Trial Master File (TMF).
Prepare and submit confirmation letters, follow-up reports, and communication logs.
Support patient recruitment, retention, and engagement strategies.
5. Project Coordination
Understand project scope, deliverables, and budgets.
Manage communication between site and sponsor teams to meet project milestones.
Participate in investigator meetings and sponsor conferences.
6. Training & Compliance
Maintain up-to-date knowledge of ICH-GCP and regulatory guidelines.
Ensure audit readiness and support audit follow-up actions.
Participate in clinical and therapeutic area training sessions.
Additional Responsibilities (Real World / Late Phase Studies)
Provide site support from initiation to close-out.
Conduct chart abstraction and real-world data collection.
Collaborate with sponsor affiliates, MSLs, and local staff.
Identify and recommend new potential sites based on local treatment practices.
Train and mentor junior CRAs as needed.
Qualifications
Bachelor’s degree or RN in a relevant field (or equivalent combination of education and experience)
Knowledge of ICH-GCP and applicable regulatory standards
Proficient computer skills and adaptability to new technologies
Excellent communication, presentation, and interpersonal skills
Ability to travel up to 75% regularly
Additional Information
Syneos Health complies with all local and international employment regulations, including the Americans with Disabilities Act (ADA).
Equivalent experience, skills, or education may be considered in place of formal qualifications.
Responsibilities may change at the company’s discretion without prior notice.
The company is committed to diversity, equity, and equal opportunity employment.
Role Summary
Clinical Research Associates (CRAs) are responsible for monitoring and ensuring compliance in clinical studies. The CRA II conducts remote and on-site monitoring to verify data integrity, safety, and regulatory adherence. Using risk-based monitoring techniques and data analytics, the CRA identifies trends and supports continuous improvement in clinical quality.
How to Apply
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