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Clinical Trial Assistant
hace 2 semanas
TFS HealthScience is excited to be expanding our Strategic Resourcing Solutions team and we are looking for an experienced, highly motivated Clinical Trial Assistant (CTA) who shares our vision of providing clinical research excellence. Our Strategic Resourcing Solutions 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.
**Main responsibilities**:
- 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
- Drafts and/or assists with the preparation of trial-related documents, tools and templates
- 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
**Benefits**:
Flexible remuneration, training/nursing
Ticket restaurant
Health Insurance
Flexibility
Compensatory hours