Clinical Research Associate Lead

Há 3 dias


São Paulo, São Paulo, Brasil PSI Tempo inteiro

Job Overview

As a Lead Clinical Research Associate, you will play a key role in managing local Monitors, overseeing clinical monitoring and site management activities to ensure 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, RN, 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 Portuguese
  • 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 unique opportunity to advance your career in clinical research. As a Lead Clinical Research Associate, you will work closely with driven and dedicated cross-functional teams, receive all the support and ownership of your projects, and have the chance to grow with the company.


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