Sector: Life Sciences
Consultant: Chris Hutchinson
Salary: £26400 - £52700
Job Status: Permanent / Full Time
Senior Clinical Research Associate (Dutch) (Homebased)
I am seeking a Healthcare professional with at least 2 years of clinical experience, or Science Graduate, 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.
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).
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.
FIH (First-in-Human Phase 1) experience is nice to have but is negotiable
Demonstrated understanding of oncology study end points
Detailed knowledge of ICH-GCP
Demonstrated understanding of clinical databases
Excellent interpersonal skills
Strong communication skills: verbal and written
Proven ability to demonstrate strong decision-making and problem solving skills
Highly organised and detail-oriented
Proven ability to meet deadlines
Basic knowledge of Windows-based software programs
If you are interested in this please get in touch and send your CV, we are looking to interview candidates as soon as possible.