Study Start Up Specialist - Hertfordshire

Recruiter
inVentiv Health Clinical
Location
Hatfield
Salary
£1 - £200 000
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Contract
Hours
Full Time
EZ/6109

Study Start Up Specialist - Hertfordshire

Office based

6 months fixed term contract (potential extension)

Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You'll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA.

We are looking for an experienced Study Start Up Specialist for a position which provides study start-up and project coordination activities for our pharmaceutical client who is based in Hertfordshire.

Responsibilities:

- Site contract follow up, startup activities, tracking, liaising with our client's and internal teams

- Conduct research and maintain proficiency of local requirements for documentation of IRB/EC and Regulatory Authorities submission/approvals and subsequent follow-up documentation
- Liaise with study sites regarding essential document collection and assisting with IRB/EC submissions.
- Customize country/site specific Patient Information Sheet and Informed Consent Forms and reviewing study documents. Set-up and maintain project files (electronic and hardcopy).
- Set-up and maintain project plan.

- Ensure all study documents are archived based on the appropriate guidelines and policy.

- Complete review of essential documents following Essential Document Checklist QC.
- Arrange and review translations of relevant study documents.
- Provide regular local status updates to SSU Project Lead; update appropriate study-tracking tools with local essential document and ethics committee status, and maintain project tracking systems for assigned projects.
- Perform administrative tasks and may perform other duties as assigned

Requirements:

- Ability to learn and follow task-specific procedures, be attentive to detail and place importance on accuracy of information
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Ability to manage time and work independently
- Strong organizational skills
- Ability to effectively interact with project team(s) and involved functions, effectively communicate in English and in the local language of the country where located
- Ability to work independently with some oversight in a fast-paced environment with a sense of urgency to match the pace.
- Must demonstrate good computer skills

Application Details:

If you have the required experience for this position and are eligible to work in the UK then please apply below or contact Ellie Zavrelova on ******************

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