Primary Function:
The Study Team Associate (STA) is a member of clinical trial team supporting delivery of clinical studies within ZaiLab to ensure the operational deliveries are executed with expected timeline, satisfying quality, and approved budget, from Protocol development through study set-up, maintenance, close-out, and study archiving.
The STA supports Study Team Leader (STL) in delegated activities and provides technical, administrative, and logistical support to ensure efficient execution of clinical trials, in line with ICH/GCP, ZaiLab SOP and regulatory regulations.
Major Responsibilities and Duties:
? Complete the delegated tasks under the guidance from STL
? Expected to work on the tasks assigned in less complicated clinical trials independently
? Lead the set-up of electronic Trial Master Files (eTMF) system, Clinical Trial Management System (CTMS). And keep the information updated during course of the study per requirement of the International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) and ZaiLab SOP
? Create and maintain the communication platforms (MS Team, SPOL, Group email list, etc) for the whole study team
? Control the access of systems deployed to a specific study, include but not limited to IxRS, EDC, CTMS and eTMF
? Support clinical trial registration and disclosure on public portal according to the requirement of regulatory authorities
? Involved in the submission package preparation (including HGR Submission) by working closely with STL, CRAs and functional stakeholders
? Contribute to the clinical trial documents development, such as study protocol, ICF, study results report and management plan per STL assignment
? Responsible for overall TMF library healthy status. Guide study team members (functionals and CRAs) on the eTMF/paper TMF documents transfer & archival, and lead Quality Check (QC) per TMF Plan
? Contribute to the finance related activities such as contract sign-off, IO & PO set-up, invoice process, budget tracker maintenance and reconciliation, including sites and third-party vendors
? Support goods purchase, document delivery, devices shipment and recycle during the conduct of clinical trial
? Coordinate and arrange the internal and external meetings, include but not limited to study team meetings, vendor defense meetings, investigator meetings, committee review meetings. And take meeting minutes/record if necessary
? Compile and maintain the clinical trial related lists and logs, include but not limited to study document version tracker, decision & issue & risk log, study contact list, Q&A log, vendor & system list, study specific training log
? Draft and distribute the newsletters/communication letters/presentation materials to internal and external stakeholders
? Complete delegated tasks during the audit and inspection by regulatory authorities
Qualifications:
*Educational Background
Bachelor’s degree or above (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution
*Working Experiences and Competencies
? Proven organizational and presentation skills
? Ability to manage multiple tasks and meticulous attention to detail
? Quick learner, good team player
? Excellent written and verbal communication skills
? Good written and spoken English
? Computer Proficiency: ability to handle daily work via Microsoft Word, Excel, PowerPoint and Outlook, etc
? Good knowledge of ICH-GCP, 1-year Experience as CTA, CRC, or other roles in the clinical trials is preferable