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.
• Coordinate, balance and facilitate activities related to the completion of Critical Document Package (CDP) and the IP release checklist (SST004-SOP-F01) in accordance with ICH GCP guidelines and all applicable regulations, laws, ethical standards, other guidelines, sponsor requirements
• Ensure that the overall process is focused on quality, efficiency and cost containment for a particular region / sub division within the CDP group, under the general mentorship of Mgr/Sr. Manager – Central Services or Designee.
· 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
· 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).