Clinical Trial Coordinator

hace 1 semana

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

About CDS Fortrea Inc.

CDS Fortrea Inc. is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.

Responsibilities:

  • Serve as the primary point of contact for project teams and investigative sites, conducting site contacts and documenting contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites.
  • Monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the Clinical Research Associate (CRA).
  • Assist CRAs with preparation for site visits (i.e. running reports, QC of files (checking for missing documents), resolving action items from previous visits).
  • Perform Case Report Form review, query generation, and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by management.
  • Assist with the coordination of study visits and shipment of drug, ancillary supplies, and laboratory kits/samples.
  • Manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines.
  • Liaise with the project team and others to distribute and track clinical trial supplies, e.g. Case Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment.
  • Proactively work with sites and project teams to ensure maintenance activities (including Amendments, revised documents, etc.) are completed for assigned sites as applicable in region.
  • Demonstrate an understanding of the purpose of CTMS, how to use it, and how to navigate within the different sections. To enter weekly details in CTMS or as per study requirement.
  • Assist in submissions and notifications to Ethics Committees and Regulatory Authorities as applicable in region.
  • Facilitate translation and back translation of all necessary documents as appropriate for local country requirements and as needed regionally.
  • Attend, as needed, meetings (investigator, sponsor, kick-off, face-to-face) and to present at the meetings.

Requirements:

  • Previous experience with Logistics / Imports / Supplies within CRO environment.
  • Completed job training (office management, administration, finance, health care preferred) or Bachelor's Degree.
  • Advanced English.
  • Good IT skills (Use of MS office and Strong MS Excel skills required).
  • Hands-on profile.

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