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Clinical Trial Assistant – CTA Junior

  • Profesionales y Técnicos
  • Full time
  • 2 semanas -
  • Madrid

Información del trabajo

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    Remuneración EUR 0-5000 / Mes

Descripción del trabajo

Work with the Study Team in initiating, maintaining and closing/final archiving of the SMF, ensuring GCP compliance

Set up and maintenance of study information in Clinical Trial Management System (CTMS) as per delegation from PM/ Lead CRA or CRA

Maintenance of electronic files

Set up the Investigator’s File as directed by the CRA

Point of contact regarding SMF

Maintain the SMF as directed by the Lead CRA/Project Manager

Coordinate study supplies as directed by the CRA

Drafts and/or assists with the preparation of trial-related documents, tools and templates

Assist in status reporting

Arrange internal and external meetings

Actively taking part in Study Team meetings and be responsible for the minutes

Prepare, contribute to and distribute presentation material for meetings and newsletter

Assist in activities associated with audits and regulatory inspections

SMF completion and preparation of shipment to sponsor as directed by the Lead CRA /CRA

Collection of appendices for final Clinical Study report

Actively contribute to the organization and development of routines to enhance the work at TFS

Work with the Study Team in all regulatory process (IEC/IRBs/CA ) including submission and amendments, regulatory fees

Assist the CRA, PM or Lead CRA managing contracts with sites, including contract status.

To manage Investigator Payments as directed by PL or Lead CRA

Assist the PL with document translations process

May support the CRAs with some monitoring remote activities: collection of documentation, follow up on data entry, queries resolution

Requirements:

Bachelor’s Degree preferred

Knowledge of GCP/ICH guidelines

Good written and communication skills

Good organizational skills

Good software and computer skills

Able to work in a fast paced environment with changing priorities

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