Clinical Research Associate Lead

hace 7 días

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

Job Title: Lead CRA

Job Summary:

We are seeking a highly skilled and experienced Lead Clinical Research Associate to join our team at PSI. As a Lead CRA, you will be responsible for managing local monitors, supervising clinical monitoring and site management activities, and ensuring the protection of trial subjects' rights, safety, and well-being.

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:

PSI is a dynamic and growing company that offers a challenging and rewarding work environment. As a Lead CRA, you will have the opportunity to advance your 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.

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