Clinical Research Coordinator

Há 19 horas

São Paulo, São Paulo, Brasil SAO Fortrea Brazil Limitada Tempo inteiro
SAO Fortrea Brazil Limitada Clinical Trials Assistant

We are seeking a highly motivated and organized Clinical Trials Assistant to join our team in Fortrea, Brazil.

About the Job

The Clinical Trials Assistant will be an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project. This role will involve performing study-related tasks as required by the department, including communication with project team members regarding study updates, maintaining documentation as required by protocols, SOPs and regulatory standards, ensuring timely production of high-quality clinical data, providing systems support, tracking information related to the status of study activities, and assisting with general administrative functions as required.

Key Responsibilities
  • Document and track study activities using relevant forms and tools, as well as relevant Project Management Systems with guidance/support.
  • Assist in the preparation of study and site-specific materials in accordance with relevant SOPs.
  • Complete minute-taking and documentation for sponsor/external or internal teleconferences as requested.
  • Assist in setting up and maintaining tracking systems/spreadsheets for e.g., study supplies.
  • Maintain the Project Directory.
  • Provide support for Investigator Meetings; track meeting attendees and/or other information regarding the Investigator Meeting.
  • Provide support to project team (e.g., proof-reading and editing correspondence, mailings, shipping of study files, faxing and photocopying documents, assembling study documents, and arranging meetings, etc.).
  • Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and/archive as applicable.
  • Audit and CAPA tracking.
  • Set up and maintain clinical investigator files and documentation.
  • Liaise with vendors, as needed, for study conduct such as printing study materials and/or external systems access for study team members.
  • Coordinate and plan study supply shipments with vendors.
  • Maintain and confirm shipment information such as courier tracking numbers and date of shipping and delivery.
  • Prepare/asemble/ship supplies to sites pre-SIV: Study File Notebooks, CRFs, other study-specific ancillary supplies (i.e., diary cards, patient visit reminders).
  • Generate reports as needed, for example CTMS site contact information list.
  • Work with the In-House CRA and other project team members on reconciliation of data with CTMS.
  • General communications to sponsors, sites, and internal team members via electronic mail or courier or telephone.
  • Perform other administrative duties as assigned by Line Manager, Project Managers, or Clinical Trial Lead.
  • All other duties as needed or assigned.
Requirements

To be considered for this role, you should have:

  • Diploma – Associate degree or equivalent.
  • In lieu of the above requirement, candidates with 1-2 or more years of relevant Clinical Research experience in pharmaceutical or CRO industries may be considered.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
  • Language Skills Required:
    • Speaking: English and local language.
    • Writing/Reading: English and local language.
Benefits

As a Clinical Trials Assistant at SAO Fortrea Brazil Limitada, you can expect a competitive salary, ranging from R$45,000 - R$60,000 per year, depending on your qualifications and experience.

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