Study Trial Associate

• The Clinical Trial Assistant (CTA) is a member of clinical trial team supporting delivery of clinical studies 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 CTA 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, relevant SOP and regulatory regulations.

What you will be doing:

• 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 ICON 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

You are:

• 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

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.