Clinical Study Start Up Specialist

Clinical Study Start Up Specialist
Suitable Locations: London, Berkshire,
Surrey
Permanent
Salary: Up to 43,000 + Benefits

Remote working: Due to the current Covid19 situation, this role will be on-boarded remotely and will be home-based for the foreseeable future.

My client (a global Clinical Research Organisation) is looking for an experienced Study Start Up Specialist to join on a permanent basis. Reporting directly into a Senior Clinical Operations Manager, you will be joining a team of up to 20 Start Up Specialists dedicated to various Start Up activities on UK studies.

Experience Required:
- Minimum 18 months study start up experience working in the CRO environment
- Must have strong EC submission experience
- Advanced level knowledge and use or IRAS system/Amendment tool
- Strong written and communication skills
- Ability to multi-task with good time management skills
- Client focused approach

Key Responsibilities:
- Customize and review, site specific Informed Consent Forms (ICF) and customize and negotiate any amendments.
- Develop strategy to manage quality country specific and/or site specific documents or essential regulatory documents and amended regulatory documentation.
- Main point of contact for the generation of country/site plans and the Study Start Up queries
- Build relationships with investigators and site staff for the management of Qualification follow-up/ site issues, site training, supplies and investigator site file set up.
- Occasional attendance on Site Initiation Visits

If you are interested in this role then feel free to apply or email directly at ed.taylor@cpl.com