ICON Clinical Research

Study Start Up Associate I

04 Jan 2021
03 Feb 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Office based in Dublin, Marlow or Southampton.

As a Study Start Up Associate I at ICON, you'll work as a member of the Study Start Up Team, you will play an integral role in making sure that physicians at our research sites are prepared to start the trial of investigational, new pharmaceutical and biological products for clinical trials at their local practices.

The Role
  • To review and negotiate contracts and budgets for both private and non-private sites across different clients
  • Stay connected with Investigative sites, sponsors and internal personnel regarding the assigned tasks per client
  • Prepare CA/EC submissions with focus on high quality documents and transparency on timelines with internal team
  • Perform Country level adaption of documents as needed per UK/Ire guidance
  • Prepare, review, submit submissions to ethics, regulatory and other authorities to obtain clinical trial authorisations and approvals.
  • Efficient and diligent collection of critical documents for IP release.
  • Requires regular system updates to ensure study status is current and accurate . Role requires individual to be comfortable with use of multiple systems
  • Work collaboratively providing support to other members of the SSU Team as needed

What you need
  • A bachelor's degree or related experience is preferred
  • SSU experience is desirable but not required.
  • Local and English language skills
  • Experience in a clinical research environment with specific experience in study submissions or contracts and budget negotiation or in related field such as where Health Authority submissions or contract or legal document review is a primary part of you role.

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