Clinical Operations Technical Assistant
|Job Title:||Clinical Operations Technical Assistant|
|Contact Name:||Lois Clear|
|Job Published:||September 01, 2017 13:59|
To ensure that essential clinical study documentation within country of responsibility is managed in compliance with Good Clinical Practices (GCP) and appropriate Quality Standards.
To provide administrative oversight and to ensure integrity and compliance to company SOPs and regulatory requirements of Investigator Initiated Studies.
To ensure local clinical operations is effectively supported with respect to system maintenance/reporting, point of contact for dealing with external submissions/questions directly or via team (where applicable)
To provide administrative support to the local Clinical Operation team.
- Clinical study document management
- Coordinator and point person for regulatory submissions/external questions
- General administration
- IIT coordination for country/cluster (when applicable)
- Good documentation practices
- GCP knowledge
- Some level of knowledge of clinical research activities
- Excellent computer skills
- Experience with the quality and documentation requirements of Clinical Operations
- Manage multiple customers, possibly in several different countries
- Knowledge of Medical Terminology
- Fluent in English (orally and written)