Job Type: Contract
Date Posted: 15 May 2018
- Joining a leading pharmaceutical company.
- An initial 12 month contract.
- Travelling to UK sites.
- Full monitoring responsibilities.
This is a fantastic opportunity for a Senior CRA to join a leading Biopharmaceutical company specialising in Early Phase Oncology trials. This would initially be a 12 month contract with the potential to be extended.
As a Senior Clinical Research Associate you will have full monitoring responsibilities across numerous sites, excellent knowledge of study regulations and strong team management.
This role is office based in the Uxbridge area, with up to 80% travel across the UK for site monitoring.
- Study set-up
- Ethics applications and submissions, reviewing translations for ICD and study documents for local authorities.
- Investigative site monitoring, SMPs, pre-study visits, monitoring visits, Trial Master Files.
- Ensure site compliance with GCP/ICH guidelines.
- Verify and submission of CRFs.
- Study Safety, including; monitoring consent procedures, safety reviews, ensuring correct dispensing.
- Attend investigator meetings.
- Liaise with Regulatory Affairs dept for submissions and changes.
- Study set-up.
- Ethics applications.
- Complex protocols.
- Strong experience as a CRA within a Pharmaceutical environment.
- Experience working in Phase I-II trials.
- Regulations- ICH, GCP, CRF, EU CT.
- Strong management experience.
- Oncology experience is preferable.
Park Street People Ltd does not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and complies with all relevant UK legislation. We are acting as an Employment Business in relation to this role.
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