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 progress of clinical trials as assigned
- Assist with the creation of critical study documents, to include 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, 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 Microsoft Office suite
This position is full‐time, and the candidate must be within commuting distance to HUYABIO’s Del Mar, CA headquarters. Interested candidates should submit resumes to email@example.com.