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 with extensive experience in clinical development, 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 necessary site communications and documenting interactions in accordance with study protocols, including generating contact reports for all communications (both outbound and inbound) with sites.
  • Evaluate site performance and collaborate with the Clinical Research Associate (CRA) to implement corrective action plans for underperforming sites.
  • Support CRAs in preparing for site visits by generating reports, ensuring quality control of files (verifying the completeness of documents), and addressing outstanding action items from prior visits.
  • Conduct reviews of Case Report Forms, generate queries, and resolve issues based on established data review guidelines, under the supervision of management on Covance or client data management systems.
  • Assist in coordinating study visits and the distribution of drugs, ancillary supplies, and laboratory kits/samples.
  • Oversee sites to ensure participant adherence to protocol requirements, study visits, and timelines.
  • Collaborate with the project team and other stakeholders to manage and track clinical trial supplies, such as Case Report Forms, study medications, and lab kits, ensuring sites are adequately stocked to continue 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 required in the region.
  • Demonstrate proficiency in the Clinical Trial Management System (CTMS), including its navigation and data entry for weekly updates or as per study requirements.
  • Assist with submissions and notifications to Ethics Committees and Regulatory Authorities as necessary in the region.
  • Facilitate the translation and back-translation of all essential documents to meet local country requirements and regional needs.
  • Attend relevant meetings (investigator, sponsor, kick-off, face-to-face) and present information as needed.

Educational Background:

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

Required Qualifications:

  • 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, particularly in MS Office and advanced MS Excel.
  • Hands-on approach to work.

CDS Fortrea Inc. is actively seeking motivated individuals who are adept at problem-solving and possess creative thinking skills. Our unwavering commitment is to enhance the development process, ensuring the efficient delivery of transformative ideas and therapies to patients in need.

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