Job Description
We're currently partnering with a leading international pharmaceutical company to recruit a Junior CRA.
Location: West London
Hybrid: Twice a week in office
DESCRIPTION OF THE ROLE
* Site evaluation and setup for commercial distribution including training of dosing in collaboration with the Clinical Project Manager or designee
1. Maintenance of contacts with sites for commercial distribution and sites which may be involved in clinical trials
2. Collection of essential documents according to ICH-GCP E6 (R2) and applicable regulations
3. Monitoring of data collection and pharmacovigilance/ safety reporting at the sites where a post authorisation study is conducted
4. Site setup, initiation, close-out and management (including monitoring) of sites participating in clinical and post-authorisation studies on an as needs basis
5. Site management including site supplies, site payment process, etc.
6. Study/clinical trial status tracking and progress update to team
7. EC/IRB and regulatory submissions
8. Participation in investigator meetings and other meetings as necessary
9. Attendance of conferences as applicable
10. Contribution to other tasks such as creation of newsletters as directed by the Clinical Project Manager or designee
11. Assist with audits as required