Job Title:
CRA II – Sponsor Dedicated (Home-Based, Argentina)
Location: Argentina (Remote)
Company: Syneos Health®
Job ID: 25102449
Updated: Yesterday
About Syneos Health
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization built to accelerate customer success. We combine clinical, medical affairs, and commercial expertise to bring therapies to market faster and more effectively.
Key Highlights:
29,000 employees across 110 countries
Worked on 94% of FDA-approved novel drugs in the last 5 years
Supported 200+ studies across 73,000 sites and 675,000+ trial patients
Our Culture – “Total Self”
We foster an inclusive workplace where you can authentically be yourself. Our Total Self culture promotes diversity, engagement, professional growth, and employee well-being.
Why Work Here
Career growth and progression opportunities
Supportive, engaged management
Comprehensive training programs
Recognition and rewards for performance
Global diversity and inclusion focus
Job Summary
The Clinical Research Associate II (CRA II) is responsible for monitoring clinical trials to ensure compliance with ICH-GCP guidelines, protocols, and regulatory standards. The role involves site management, monitoring, data review, and supporting study quality across all trial phases.
Key Responsibilities
Site Management & Monitoring
Conduct site qualification, initiation, interim, and close-out visits (on-site or remote).
Evaluate site and staff performance and recommend improvements.
Ensure compliance with ICH-GCP, GPP, and regulatory guidelines.
Patient Safety & Data Integrity
Verify informed consent documentation and process.
Monitor subject safety, protocol deviations, and pharmacovigilance issues.
Conduct source document review and confirm CRF data accuracy and completeness.
Apply query resolution techniques to drive data closure within timelines.
Investigational Product (IP) Oversight
Perform IP inventory, reconciliation, and security checks.
Verify correct IP dispensing and administration.
Ensure compliance with labeling, import, release, and return processes.
Documentation & Reporting
Maintain Investigator Site File (ISF) accuracy and reconcile with the Trial Master File (TMF).
Prepare confirmation letters, follow-up reports, trip reports, and communication logs.
Support recruitment and retention strategies.
Project Coordination
Understand project scope, timelines, and budgets.
Manage site-level communication to meet objectives and deliverables.
Participate in investigator meetings and sponsor communications.
Compliance & Training
Ensure audit readiness and support audit follow-up.
Maintain up-to-date knowledge of ICH-GCP, regulations, and SOPs.
Attend project-specific and therapeutic area training sessions.
Additional Responsibilities (Real World / Late Phase Studies)
Provide site support from initiation to close-out.
Conduct chart abstraction and data collection.
Collaborate with sponsor affiliates, MSLs, and local staff.
Identify potential new sites based on local healthcare networks.
Mentor and train junior CRAs when required.
Qualifications
Bachelor’s degree or RN in a related field (or equivalent education/experience)
Strong knowledge of ICH-GCP and applicable regulations
Proficiency in computer systems and willingness to learn new technologies
Excellent communication and interpersonal skills
Ability to travel up to 75% regularly
Additional Information
Syneos Health complies with the Americans with Disabilities Act (ADA) and provides reasonable accommodations.
Tasks and responsibilities may change at the company’s discretion.
Equivalent skills or experience may be considered in lieu of listed qualifications.
Commitment to diversity, equity, and inclusion across all roles.
Summary
Roles in Clinical Monitoring / CRA are focused on ensuring the integrity and compliance of clinical trials. The CRA II uses data analytics and risk-based monitoring techniques to identify issues, ensure quality, and collaborate with site teams to improve study outcomes.
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