Senior Clinical Research Associate (General Rodríguez)

Senior Clinical Research Associate (Argentina) Remote, Argentina

We’re expanding our capabilities across Latin America, and we’re hiring a Senior Clinical Research Associate to support critical studies across Argentina.

As a Senior CRA you'll possess a wide-ranging and broad experience handling our most complex and advanced assignments. Responsibilities will depend upon the type and timing of the program to which the Senior CRA is assigned and will, at minimum, include start-up and study implementation activities, on-site monitoring of clinical research studies as well as ongoing site management. Incumbents are expected to manage appropriately sized or complex clinical trials, and support Clinical Trial Managers and/or Project Managers with trials as required. An increased focus on training and mentoring junior staff members may be expected.

Responsibilities:
- Independently oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions
- Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports
- Manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager
- If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee
- Verifies the Postúlate en Kit Empleo: kitempleo.com.ar/empleo/qbefl