Senior Clinical Trial Coordinator

hace 2 semanas

Bogotá, Bogotá D.E., Colombia CDS Fortrea Inc. A tiempo completo

As a prominent global contract research organization (CRO) dedicated to scientific excellence and extensive clinical development expertise, CDS Fortrea Inc. offers pharmaceutical, biotechnology, and medical device clients a comprehensive array of clinical development, patient access, and technological solutions across over 20 therapeutic areas. With a workforce exceeding 19,000 professionals operating in more than 90 countries, CDS Fortrea Inc. is at the forefront of transforming drug and device development for partners and patients worldwide.

Key Responsibilities:
  • Act as the primary liaison for project teams and investigative sites, conducting site communications and documenting interactions as required by study protocols, including generating contact reports for each communication with sites.
  • Evaluate site performance and implement corrective action plans for underperforming sites in collaboration with the Clinical Research Associate (CRA).
  • Support CRAs in preparing for site visits by generating reports, performing quality control of files (verifying the completeness of documents), and addressing outstanding action items from prior visits.
  • Conduct Case Report Form reviews, generate queries, and resolve issues in accordance with established data review protocols, under the direct supervision of management on Covance or client data management systems.
  • Assist in coordinating study visits and the distribution of investigational products, ancillary supplies, and laboratory kits/samples.
  • Oversee sites to ensure compliance with protocol requirements, study visits, and timelines.
  • Collaborate with the project team and others to manage and track clinical trial supplies, such as Case Report Forms, study medications, and lab kits, ensuring sites have adequate resources for participant recruitment.
  • Proactively engage with sites and project teams to ensure that maintenance activities (including amendments and revised documents) are completed for assigned sites as necessary within the region.
  • Demonstrate proficiency in the Clinical Trial Management System (CTMS), including its navigation and functionality, to input weekly details as per study requirements.
  • Assist with submissions and notifications to Ethics Committees and Regulatory Authorities as required within the region.
  • Facilitate the translation and back-translation of all necessary documents in accordance with local country requirements and regional needs.
  • Attend and present at meetings (investigator, sponsor, kick-off, face-to-face) as necessary.

Education:

  • Bachelor’s degree (preferably in Life Sciences).

Requirements:

  • Prior experience in Logistics / Imports / Supplies within a CRO environment.
  • Completion of job training (office management, administration, finance, healthcare preferred) or a Bachelor’s degree.
  • Proficient in English.
  • Strong IT skills, including proficiency in MS Office and advanced MS Excel capabilities.
  • Hands-on approach to tasks.

CDS Fortrea Inc. is seeking motivated problem-solvers and innovative thinkers who share a commitment to overcoming challenges in clinical trials. Our dedication is to revolutionize the development process, ensuring the timely delivery of transformative ideas and therapies to patients in need.

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