Clinical Trial Assistant

Come join our world-class team evaluating, in-licensing, and developing innovative therapeutic products internationally. 

HUYABIO International is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective, and lower-risk drug development in the global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. With offices in the US, Japan, South Korea, Canada, Ireland, and eight strategic locations across China, the Company has become a partner of choice to accelerate product development and maximize value globally. For more information, please visit www.huyabio.com.

Job Summary

The Clinical Trial Assistant will provide administrative support to HUYABIO’s Clinical Operations department within the planning, start-up, maintenance, and closeout of clinical studies being conducted on a global scale. The incumbent will be responsible for coordinating in-house operational aspects of clinical studies and the processing of data that is generated throughout clinical trials.
This is an office-based position that works in a cross-functional and dynamic environment. Clear, timely, professional, and effective communication with all HUYA functional areas and global office sites are essential.

Primary Duties and Responsibilities

• Track and maintain study information and report on the progress of clinical trials as assigned
• Assist with the creation of critical study documents, including ICFs, study reference documents, study newsletters, site material, and other related documents
• Assist in the collection and tracking of documents during site start-up
• Review study-specific regulatory document packets prior to site activation
• Responsible for the submission of documents to and maintenance of the TMF, along with coordinating the review of the eTMF to ensure inspection readiness at all times
• Participate in internal project team meetings; prepare and distribute agenda, minutes, and action items for internal and external teams
• Update TMF, CTMS, IMP management systems, etc as required
• Support preparation activities for FDA and other regulatory body meetings and inspections, as well as internal audits
• Participate in SOP and/or internal template development and review
• Participate in vendor management activities
• Provide administrative support to the clinical team, as needed
• Other duties as assigned

Job Qualifications and Requirements

• Bachelor’s degree in life sciences or other relevant field preferred
• 2+ years’ experience in the coordination of Phase I to III clinical trials
• Experience working within a pharmaceutical, biotech, CRO, academic institution, or site management organization desired
• Experience within ICH, GCP, and FDA guidelines
• Ability to communicate clearly both verbally and written to sites, vendors, CROs, internal study team, etc.
• Ability to take initiative, prioritize, and execute tasks and special projects with minimal direction or supervision, maintaining a high level of confidentiality, integrity, and discretion at all times.
• Proficiency with computer programs such as the Microsoft Office suite