Country Study Specialist
CK Clinical are recruiting for a Country Study Start Up Specialist to join a global bio-pharmaceutical company at their site based in Welwyn Garden City, Hertfordshire on an initial 6 month contract basis.
This company is one of the world's largest biotech companies which is a leading provider of both cancer treatments and in vitro diagnostics.
This Country Study Start Up Specialist is based at our clients UK head office in Welwyn Garden City. The HQ is easy to reach by road (A1M) and also rail (25 minutes to Kings Cross).
Country Study Start Up Specialist:
As the Country SSUS you will be responsible for all the SSU-related activities in the UK, on assigned studies, overseeing and leading SSU activities in collaboration with other clinical research colleagues and stakeholders.
Other responsibilities include:
- Ensure compliance with local regulations and internal procedures.
- Execute all start-up activities prior to site activation on assigned studies.
- Prepare country level Informed Consent Form (ICF) and obtain ethics committees' and local regulatory authorities' approval.
- Prepare ongoing submissions, amendments and periodic notifications required by ethics committees and regulatory authorities.
- University degree or equivalent work experience, in a medical/science field.
- Demonstrable knowledge and understanding of clinical trials and experience in managing projects.
- Demonstrable knowledge and understanding of ICH-GCP, regulatory, ethics, and contractual requirements for startup of trials in the UK.
- Previous UK clinical project management experience preferred.
For more information or to apply for this Country Study Start Up Specialist, please contact Steve on 01246 457 738 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 47525 in all correspondence.