ICON Clinical Research

Study Start Up Associate II - Medical Devices

18 Jan 2021
27 Jan 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
As a Study Start Up Associate I "Medical Device" 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 trials on pre-market or post-market Medical Devices.

The Role
  • To review and negotiate clinical site investigator contracts and budgets.
  • Stay connected with Investigative sites, sponsors and internal personnel regarding the status of contracts and contract-related documents
  • Prepare and coordinate preparation of contractual documents and correspondence
  • Facilitate the indemnification process between the study sponsor and the site.
  • Perform regulatory document for maintenance e.g. amendments, periodic updates and safety letters.
  • Prepare, review, submit and QC submissions to ethics, regulatory and other authorities to obtain clinical trials or late phase studies authorizations and approvals.
  • Collect critical documents for MD release.

What you need
  • A bachelor's degree or related experience is preferred
  • 2 year of SSU experience in Medical devices area.
  • Local language and English language skills
  • Experience in a clinical research environment with specific experience in study submissions or contracts review and budget negotiation or in related field such as where submissions or contract or legal document review is a primary part of you role, but required in Medical Device area.

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