Clinical Research Coordinator

hace 2 días

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

At PSI CRO, we are seeking a highly skilled Clinical Research Coordinator to join our international team. As a key support to clinical research projects, you will be responsible for streamlining communication, maintaining systems, and managing documents & information.

Responsibilities:

  • Act as the main point of contact between site personnel and CRA involved in the project, helping with query resolution and EDC completion.
  • Serve as the primary site's contact point for vendors, study supplies, and access management.
  • Ensure that pre-study testing of local site facilities is completed.
  • Assist monitors in completing subject event and site event information in CTMS, tracking resolution status of site issues and action items.
  • Manage the order, receipt, inventory storage, distribution, return/recall, and reconciliation of clinical supplies.
  • Ensure regulatory and ethics committee submissions and notifications, staying up-to-date on local regulations and dispositions.
  • Coordinate preparation for and follow-up on site, TMF, and systems audits and inspections.
  • Manage the TMF on a site and country level, preparing, distributing, and updating Investigator Site Files (ISF) and ISF checklists.
  • Arrange and track initial and ongoing project training for site teams in all 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.

Additional Information:

Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.

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