In this position you will be involved in some or all of the following tasks at any given time:
1. Study related activities (Laboratory Support). Manages all laboratory related activities within a clinical study under supervision, including:
- Reviews study documents
- Provides expert advice to PSI and Sponsor study teams
- Contributes to the development of diagnostic strategies, including the development and review of assay validation plans and reports
- Documents and drives the Laboratory Strategy
- Presents laboratory strategy at kick-off meetings
- Supports the selection of central and regional laboratories for studies
- Performs qualification of off-site / on-site laboratories for a study
- Coordinates the contracting of central / regional / off-site laboratories
- Performs central / regional / off-site laboratory set up
- Contributes to Risk Management process
- Provides information to PSI Data Management (DM) to aid eCRF design
- Delivers training to the study team and/or clinical sites in laboratory related procedures
- Performs initiation and monitoring visits to laboratories as required
- Coordinates routine calls with central laboratories
- Attends study progress calls with the Sponsor
- Provides support / consultancy to Sponsor / PSI team for all laboratory related issues
- Investigates issues with laboratories / couriers / sites
- Coordinates the transfer of samples between laboratories
- Assists DM in on-going data reconciliation
- Coordinates any changes to the laboratory strategy
- Performs close out of central / regional off-site laboratories
2. Quality Control & Quality Assurance:
- Develops and/or implements operational (project specific and laboratory specific) quality control documents
- Participates in system audits and follows up on audit findings related to laboratories that provide testing for the assigned projects
3. Business Development:
- May be required to assist with consultancy in business development tasks
