Clinical Trial Operations Specialist

hace 1 semana

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

CDS Fortrea Inc. is seeking a motivated Clinical Trial Operations Specialist to join our team.

Job Description

We are actively seeking a talented individual to manage site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA.

  • Serve as contact for project team and investigative sites, conduct site contacts and document 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 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).
Responsibilities

The selected candidate will be responsible for:

  • Performing 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.
  • Assisting with the coordination of study visits and shipment of drug, ancillary supplies and laboratory kits/samples.
  • Managing sites to ensure subjects are complying with protocol requirements, study visits, and timelines.
  • Liaising 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 working with sites and project teams to ensure maintenance activities (including Amendments, revised documents, etc.) are completed for assigned sites as applicable in region.
  • Demonstrating 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.
  • Assisting in submissions and notifications to Ethics Committees and Regulatory Authorities as applicable in region.
  • Facilitating translation and back translation of all necessary documents as appropriate for local country requirements and as needed regionally.
Requirements

The ideal candidate will possess:

  • A BA (Life Science preferred)
  • 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
Estimated Salary: $70,000 - $90,000 per year

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