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Clinical Research Associate Lead

hace 2 meses

Bogotá, Bogotá D.E., Colombia PSI A tiempo completo

Job Overview

As a Clinical Research Associate Lead at PSI, you will play a critical role in ensuring the success of our clinical trials. Your primary responsibility will be to manage local Monitors, supervising clinical monitoring and site management activities to verify the protection of trial subjects' rights, safety, and well-being, data quality, and study compliance on a country/regional level.

Key Responsibilities

  • Facilitate regional projects as Lead Monitor and supervise study activities, timelines, and schedules.
  • Train Monitors in annotated monitoring visit reports.
  • Review monitoring reports and support monitors in their activities.
  • Act as the main communication line between Monitor and Regional Lead.
  • Facilitate site budgets and contract negotiations.
  • Be a point of contact for in-house support services and vendors.
  • Communicate with internal project teams regarding study progress and lead project team calls on the country level.
  • Participate in quality control and compliance monitoring.
  • May need to monitor and manage sites (if applicable).
  • May need to supervise monitors on site.
  • Oversee and maintain study-specific and corporate tracking systems at site and country level.

Requirements

  • College/University degree in Life Sciences, Pharmacy, or an equivalent combination of education, training, and experience.
  • Participation in clinical projects as a Lead/Senior Monitor.
  • At least 4 years of experience as Senior CRA.
  • Independent on-site monitoring experience.
  • Full working proficiency in English and Spanish.
  • PC skills to be able to work with MS Word, Excel, and PowerPoint.
  • Ability to plan, multitask, and work in a dynamic team environment.
  • Communication, leadership, and problem-solving skills.
  • Ability to travel.

About PSI

At PSI, we are committed to advancing our career in clinical research, overseeing a variety of tasks, and growing with the company. You will work closely with driven and dedicated cross-functional teams, get all support, and ownership of your projects.