23 oct
|
Atlas Search
|
Argentina
23 oct
Atlas Search
Argentina
We are partnered with a growing company that is seeking a Senior Clinical Research Associate. The Senior Clinical Research Associate is responsible for the overall management and oversight of assigned clinical trial sites, including site identification, feasibility assessments, pre-study evaluations, study start-up, site initiation, patient recruitment, site monitoring, close-out activities, inspection readiness, and local regulatory and IRB/EC submissions. This role ensures clinical studies are conducted in accordance with study protocols, Standard Operating Procedures (SOPs), ICH-GCP guidelines, and all applicable regulatory requirements while supporting the successful execution of clinical programs.
Responsibilities:
- Oversee the successful start-up, monitoring, and execution of Phase I–IV clinical studies at assigned investigative sites.
- Conduct clinical site management and monitoring activities in compliance with ICH-GCP guidelines, Standard Operating Procedures (SOPs), study protocols, applicable study plans, local regulations, and internal working procedures.
- Serve as the primary point of contact for assigned clinical sites throughout the entire study lifecycle, from site start-up through close-out.
- Coordinate monitoring schedules and ensure timely completion of site visits, data entry, and study milestones at assigned sites.
- Perform routine monitoring activities, including source data verification (SDV), to ensure data integrity, protocol compliance, and adherence to established study timelines.
- Build, maintain, and strengthen relationships with investigators and site personnel to promote effective communication, site engagement, and successful study execution.
Qualifications:
- MUST be bilingual including 100% fluent in English
- 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
- Detailed understanding of all aspects of clinical site monitoring and understanding of overall drug development.
📌 Senior Clinical Research Associate (Argentina)
🏢 Atlas Search
📍 Argentina