10 ago
|
Codera Codera
|
Buenos Aires
10 ago
Codera Codera
Buenos Aires
About Codera
Codera is a Tang Capital company that provides in-house end-to-end drug development capabilities for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products.
Position Summary
The Site Director, Clinical Operations is responsible for overall clinical site management, including site identification, feasibility, pre-study site evaluation, study start-up, site initiation, patient recruitment, monitoring, site close-out activities, inspection readiness and local regulatory and IRB/EC submissions of Codera’s clinical studies at designated sites in accordance with study protocol(s), Standard Operating Procedures (SOPs), ICH-GCP guidelines and all applicable regulatory requirements. Using available systems and tools, the Site Director, Clinical Operations will monitor and oversee site activities both onsite and remotely to ensure that patients’ rights,
safety and well-being are protected and that the data generated at sites are complete and accurate. The Site Director, Clinical Operations will be accountable for patient enrollment and overall delivery of high-quality patient data in established timelines for all designated sites and/or assigned region.
Essential Duties and Responsibilities
•Responsible for the successful start-up, monitoring and execution of Phase I-IV studies at assigned clinical sites
•Perform clinical site management and monitoring activities in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines
•Serve as primary point of contact for clinical sites through all phases from start-up to close-out of clinical studies
•Arrange for monitoring availability and ensure data entry timelines are maintained at assigned sites
Perform required monitoring, including required source data verification, and ensure
📌 Clinical Research Associate (Buenos Aires)
🏢 Codera Codera
📍 Buenos Aires