Cta Junior

hace 1 semana

Barcelona, España TFS A tiempo completo

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

**Benefits**:
Flexible working times
TFS Academy training courses
Free Private Health Insurance (CIGNA)
Flexible remuneration scheme including Nursery ticket and Training

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