CTA JUNIOR (Clinical Trial Associate) - sponsor dedicated (Barcelona)
TFS Trial Form Support International AB
Barcelona, Spain, Cataluña, Spain
hace 4 días
source : Pharmiweb
  • Description* 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* 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*Education*Bachelor's Degree*Experience*Entry level*Benefits*Flexible working timesTFS Academy training coursesFree Private Health Insurance (CIGNA)Flexible remuneration scheme including Nursery ticket and Training

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