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Clinical Study Start-Up Associate Job For BSc Life Science At ICON
Job Position: SSUA- I & II(Study Start-up Associate)/ SSA (Study Support Assistant)
Company Name: ICON
Job id: JR108915
Job Category: ICON Full Service & Corporate Support
Job Type: Office Based
SSUA-I & II(Study Start Up Associate)/ SSA (Study Support Assistant):
The Role:
- Review of site level essential documents ensuring that Sponsor and Investigator obligations are being met and are in compliance with ICON SOPs/WIs, Sponsor SOPs, applicable country requirements and ICH/GCP guidelines.
- Update systems in a timely and accurate way, maintaining site-related data in applicable clinical systems according to procedures and guidelines.
- Preparation and Submission of Investigational Product Release Pack.
- Ensure accuracy and timely completeness of Trial Master File (TMF) documents by submitting the documents for filing to TMF during start-up.
- Perform timely and accurate task progress communication.
- Be highly organized in an environment with shifting priorities.
- Interact successfully with internal stakeholders.
- Performs all tasks in accordance with applicable guidelines, (e.g., ICH-GCP), company and sponsor SOPs, project plan, study- specific processes, local regulatory requirements.
- Flexible to support on various other tasks apart from document management process
- 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.
- Function as the internal consultant on study budgets (investigator payments, develop and update training documentation and conduct group training as necessary, mentor and train new and junior personnel in the SSU department, and act as consultant on the Investigator Contract and Budget development process from origination through execution).
Qualification:
- Bachelor’s Degree in a life science related field or relevant/equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities.
- Knowledge of ICH GCP and Prior clinical research experience with a minimum of 1-7 years’ experience in Essential Document review, filing documents in TMF and checking TMF completeness and readiness.
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