Jr Clinical Trial Assistant

hace 2 semanas

Barcelona, España TFS A tiempo completo

TFS HealthScience is excited to be expanding our SRS team and we are looking for an experienced, highly motivated Junior Clinical Trial Assistant who shares our vision of providing clinical research excellence. Our SRS team is a highly experienced international group of professionals led by an industry expert.
We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.
Our cores values of Trust, Quality, Flexibility and Passion are what makes TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organisation. Together we make a difference.
This role will sit embedded within one of our prestigious clients who promotes rapid career development.

**Reponsibilities**:

- 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
- At least few months of experience in related positions (CTA, Study Coordinator, Data Entry, etc)
- 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)
Ticket restaurant
Flexible remuneration scheme including Nursery ticket and Training

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