Description
The Clinical Trial Associate will complete tasks assigned by the Study Team that will enable them to meet project goals and deliverables for all phases of the clinical trial process. Tasks may include creating regulatory and general communication documents as well as coordinating internal Study Team processes to meet safety and regulatory requirements as outlined in the Standard Operating Procedures. This position requires prior experience maintaining Trial Master Files (reviewing for completeness, accuracy, filing etc.)Skills:
- 2+ years industry experience in equivalent role
- Able to communicate clearly and accurately both written and spoken in English
- Experience working as part of a team
- TMF management
- Self-motivated and displays initiative
- General knowledge of medical/scientific terminology and ICH/GCP guidelines
- Detail oriented
- Has experience using various computer applications including spreadsheets, email and word-processing software
Education: Bachelors degree or equivalent undergraduate degree required (scientific or healthcare discipline preferred); Working knowledge of international regulatory and ICH GCP guidelines