Role Summary
A Study Start-Up (SSU) Specialist at Bestat is to assist and perform SSU-related activities and pharmacovigilance (PV) in clinical trials. An SSU Specialist will work closely with various clinical research professionals, including but not limited to Bestat members, trial investigators, study site personnel, sponsors, and more. An SSU Specialist adheres to the ICH GCP and applicable regulations, and they may facilitate, process, and update activities relating to study sites governed by the ethics committee/institutional review board (EC/IRB) and regional/national health agencies throughout the investigation.
Responsibilities
◼Develop and maintain documents in regulatory compliance and study site management
◼Participate and assist in PV activities, which may include receiving, processing, submitting, and maintaining safety and regulatory data/reports
◼Engage in communication with study sites, the respective EC/IRB, and health authorities as appropriate
◼Assist Bestat and relevant parties in better understanding and streamlining SSU policies and processes as appropriate
◼Address and facilitate site-related issues and considerations raised by sponsors, investigators, study sites, and health authorities as appropriate
◼With help from Regulatory Specialist and Regulatory Affairs Manager, an SSU Specialist may participate and assist in PV
◼Complete EDC, safety management, and SSU-related system access training and certification as instructed
◼Complete SSU activities in clinical trials
◼Provide support to all members at Bestat as appropriate
