Clinical Research Coordinator

hace 1 mes

Bogotá, Bogotá D.E., Colombia Psi Cro A tiempo completo

Job Overview

Psi Cro is a dynamic, global company founded in 1995, bringing together over 2,800 driven individuals working on the frontline of medical science.

Estimated Salary: $60,000 - $80,000 per year

Job Description

We are seeking a highly organized Clinical Research Coordinator to join our international team. As the primary site contact point, you will be responsible for ensuring smooth communication and document management throughout clinical research projects.

Main Responsibilities

  • Act as the main point of contact between site personnel and CRA involved in the project
  • Help resolve queries and complete EDCs efficiently
  • Serve as the primary site contact point for vendors, study supplies, and access management
  • Ensure pre-study testing of local site facilities is completed
  • Assist Monitors in completing subject event and site event information in CTMS
  • Track resolution status of site issues and action items in CTMS
  • Manage the order, receipt, inventory storage, distribution, return/recall, and reconciliation of clinical supplies
  • Ensure regulatory and ethics committee submissions and notifications are up-to-date
  • Coordinate preparation for and follow-up on site, TMF, and systems audits and inspections
  • Manage the TMF on a site and country level, filing documents regularly
  • Prepare, distribute, and update Investigator Site Files (ISF) and ISF checklists
  • Arrange and track initial and ongoing project training for site teams in vendor-related systems
  • Document Management and translations status review of the study
  • Ensure proper safety information flow with investigative sites

Qualifications

  • College/University Degree in Life Sciences
  • Administrative work experience, preferably in an international setting
  • Prior experience working as a CTA for CROs
  • Prior experience working in Clinical Research
  • Local regulations knowledge
  • Full working proficiency in English and Spanish
  • Proficiency in MS Office applications
  • Ability to plan and work in a dynamic team environment
  • Communication and collaboration skills

Become Part of Our Team

At Psi Cro, we offer opportunities for career growth and development in a dynamic environment. If you're passionate about clinical research and possess excellent organizational skills, we encourage you to apply for this exciting opportunity.

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