Clinical Trial Assistant
Based in Menlo Park, CA since 2018, Zai Lab U.S. is focused on discovering and developing novel therapies for the treatment of cancer and inflammatory diseases. We are an innovative, research-based, commercial stage company, with over 1,600 employees worldwide and a diversified and strong pipeline poised for continued growth. This is an exciting time for us as we build our R&D Drug Discovery team and advance our global pipeline, aiming to produce 1-2 global INDs per year.
The Clinical Trial Assistant (CTA) is a member if the clinical trial team supporting delivery of clinical studies within Zai Lab. The CTA will support the study team to ensure the operational deliveries are executed within the expected timeline, approved budget, and at high quality from protocol development through study set-up, 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, Zai Lab SOPs, and regulatory regulations.
- Lead the set-up of the electronic Trial Master File (eTMF) system and Clinical Trial Management System (CTMS). Ensure information is updated during the course of the study per ICH/GCP and Zai Lab SOPs.
- Create and maintain communication platforms (i.e. MS Teams, SPOL, group email list) for the study team.
- Control systems access for assigned study(ies), including but not limited to IxRS, EDC, CTMS, and eTMF.
- Support clinical trial registration and disclosure on public 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.
- Facilitate finance related activities such as contract sign-ff, IO and PO set-up, processing invoices, and budget tracker maintenance and reconciliation for sites and third-party vendors.
- Coordination and tracking of clinical supplies.
- Coordinate and arrange internal and external meetings, including but not limited to study team meetings, vendor defense meetings, Investigator Meetings, and committee review meetings. 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/issue/risk log, study contact list, Q&A log, vendor list, and study specific training log.
- Draft and distribute newsletters/communications/presentation materials to internal and external stakeholders.
- Complete delegated tasks during audit and inspection by regulatory authorities.
- Expected to work on tasks assigned in less complicated clinical trials independently.
- Bachelor’s degree or above (Life Sciences preferred) or certification in a related health profession (i.e. nursing, medical or laboratory technology) from an accredited institution.
- Proven organizational and presentation skills.
- Ability to manage multiple tasks meticulous attention to detail.
- Quick learner and a team player.
- Excellent written and verbal communication skills.
- Computer proficiency in Microsoft Word, Excel, PowerPoint and Outlook.
- Good knowledge of ICH/GCP.
- One year experience as a CTA, CRC, or other role in clinical trials is preferable.
Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability.