Senior Clinical Research Associate, Mexico

Role Overview

• 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...
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team...
• Supports the design and development of CRFs and clinical trial documents as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.)
• Functions as a mentor, assisting with the training and developing of new employees and junior monitors.

Requirements

• 4-year college degree or equivalent experience in a scientific or healthcare discipline
• 5 years or more as a CRA in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies
• Significant site management experience or equivalent experience in clinical research
• Ability to communicate both verbally and in writing at the English proficiently (Professional level).

Benefits

• Health insurance
• Professional development opportunities