Consultant: Chris Hutchinson
Salary: £35000 - £45000
Job Status: Permanent / Full Time
Due to international expansion, we are currently searching for a Senior Clinical Research Associate (Home based) The company is based in West Sussex and the ideal candidate we would be looking for is a healthcare professional with at least 2 years of clinical experience or Science Graduate.
This position involves international/national travel as needed to meet study requirements (this may be on average 2 – 3 days per week and involve overnight stays).
JOB SUMMARY: The primary responsibilities of this position include, but are not limited to, the following:
1. Act as the routine liaison between study site and the project team for study related issues.
2. Conduct pre-qualification, initiation, routine monitoring and close-out visits in accordance with the relevant SOPs.
3. Serve as a mentor to project specific staff. Prepare and deliver staff training sessions and conduct CRA training visits.
4. Provide support to the Project Manager as required.
5. Assist in the day to day running of projects assigned.
6. Liaise between Oncology and Sponsor representatives as required in consultation with the PM
7. Assist in the review of protocol, amendments, Informed Consent Forms.
8. Assist in the co-ordination and development of study start up materials, e.g., SOP, draft CRFs, completion manual, compliance forms, study prompters/calendars, study operations manuals.
9. Assist in the preparation of project specific materials e.g., status reports, newsletters, templates, etc.
10. Perform clinical reviews of individual patient listings.
11. Translate study documents as appropriate.
12. Participate in project administration as required e.g., photocopying, binder preparation, start-up pack preparation etc.
13. Maintain an awareness of the literature on cancer therapy, clinical trial design and conduct, and good clinical practice.
Essential Qualifications and Skills:
Must have Oncology experience
At least 2 years’ experience as a Clinical Research Associate with a sound track record in managing clinical trial sites
Fluent in English and at least one other European language
Demonstrated understanding of oncology study endpoints
Detailed knowledge of ICH-GCP
Demonstrated understanding of clinical databases
Much of the work is required to be conducted in compliance with relevant Standard Operating Procedures.