Join our Clinical Operations team and help support the successful delivery of global clinical trials. As a Clinical Operations Administrative Support (COAS) you will provide administrative and operational support to clinical trial project teams, helping ensure studies are conducted efficiently, documentation is maintained accurately, and clinical sites receive the support they need throughout the trial lifecycle. This is an excellent opportunity for someone looking to build a career in clinical research.
- Exchanges project-specific information and documents with other PSI departments, sites and vendors
- Maintains information in study-specific and corporate tracking systems
- Supports regulatory and ethics committee submissions and notifications
- Assists with organization of internal team meetings
- Under supervision, coordinates sites payments within the project team
- Under supervision, prepares draft agendas for, and minutes of, internal team meetings
- Under supervision, assists with preparation, conduct and follow-up of Investigator Meetings
- Assists with clinical supplies order, receipt, inventory storage, distribution, return/recall and reconciliation at either PSI warehouse or as defined by the project team
- Assists with preparation for and follow-up on TMF and systems audits and inspections
- Under supervision maintains, performs regular periodic checks of, and files study related documents in the TMF on a site and country level
- Under supervision prepares, distributes, and updates Investigator Site Files (ISF) and ISF checklists
- Assists with translations of study-specific documents
- Under supervision, assists with safety information flow with investigative sites
- Other departmental assignments, as necessary