About the job

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. As the world’s largest FSP organization, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

What you will be doing:

The Clinical Trial Assistant is a member of the clinical trial team supporting delivery of clinical studies within the sponsor. The CTA will support the study team to ensure the operational deliveries are executed then the expected timeline, approved budget, and at high quality from protocol development through study setup, maintenance, close out and study archiving.

• The CTA supports the study team in delegated activities and provides technical, administrative and logistical support to ensure efficient execution of clinical trials in line with ICH/GCP sponsor SOP's and regulatory regulations.
• Lead the setup of electronic Trial Master File (eTMF) system and clinical trial management (CTMS). Ensure information is updated during the study per ICH/GCP and sponsor SOP's
• Create and maintain communication platforms (i.e. MS Teams, SPOL, group e-mail list) for the study team
• Control systems access for assigned studies but not limited to IxRS, EDC, CT's, and eTMF
• Support clinical trial registration and disclosure on websites per applicable regulatory requirements
• Responsible for overall TMF status. Guide study team members on the eTMF/paper TMF document transfer and archival. Lead the quality check (QC) per the TMF plan. Help draft TMF plan
• Facilitate finance related activities such as sign off, IO and PO setup, processing invoices, track accruals and budget for maintenance and reconciliation for sites and third-party vendors
• Support oversight of monitoring visit report review. Activities include updating MVR trackers and overseeing MVR review metrics
• May support data oversight and reconciliation efforts vendor systems, SAEs, protocol deviations and more as needed per study
• Coordination and tracking of clinical supplies
• Coordinate and arrange internal and external meetings, including but not to study team meetings, vendor defense meetings, investigator meetings, and committee review meeting take meeting minutes as needed.
• Compile and maintain the clinical trial related lists and logs, including but not limited to study document version tracker, decision risk log, contact list, Q&A log, vendor list, and specific training log.
• Draft and distribute newsletters communications Asia materials to internal and external stakeholders
• Complete delegated tasks during audit and inspection by regulatory authorities