As Start Up Associate(SSUA), you will be responsible for the start up activities, start post country allocation and ends at completion of Site Initiation Visits for Clinical Trials conducted in Clinical Development Center (CDC) Korea.
The nature and scope of main accountabilities includes but not limited to:
• Prepare essential clinical trial documents such as confidentiality disclosure agreements (CDA) and Investigator’s Brochure(IB) & Summary of Product Characteristics(SmPC) receipts if required, protocol signature page and other relevant documents for Feasibility, Site Selection and Clinical Trial Application (CTA), also uploading all CDAs to Contract Management System (COUPA) and maintaining log of IB & SmPC external distribution if required until site initiations and hands it over to Clinical Research Associate(CRA)
• Prepare Institutional Review Board(IRB) submission package and IRB application including IRB review schedule, review fee, list of required documents etc. by site, also dispatching IRB dossiers to sites for getting a final approval in close collaboration with CDC project manager, CRA and clinical managers.
• Make site level budgets and contracts such as site specific Investigator Agreement master templates for ensuring necessary review and approvals are in place by legal and customizing site level contract and budget draft in collaboration with Clinical Development Center-Project Manager(CDC-PM) and execute Investigator Agreement timely prior to site initiation/activation
• Uploading and filing all documents generated till site initiations starting with Quality Control(QC) workflow if required.
• Bachelor’s degree or higher is essential, preferably in the discipline of Life Sciences, Medicine or Pharmacy.
• At least 2 years of experience as CRA/SSU preferably with site start up and budget negotiation task
• Experience in 2-4 multinational clinical trials phase 2-3 from site start up till site closure