CTA

Summary This position reports to Clinical Operation Director, Gan & Lee Pharmaceuticals USA Corporation or designee.

This role is responsible for working side-by-side with the Clinical Operations Team, assisting with day-to-day management of clinical studies.

Education and Credentials College degree in relevant field or equivalent years of direct industry related experience.

Experience At least 3 - 8 years of industry experience.

Skills Must have good communication skills (both oral and written).

Ability to work in cross-functional team.

Willingness to adapt to changing priorities and assignments.

Familiarity with Microsoft Suite of applications including Word, Excel, Project, and PowerPoint.

Efficient, organized, and capable of multitasking.

Working knowledge of GCP standards, ICH, and Federal Regulations.

Process oriented with a strong attention to detail.

Self-motivator.

Team player who thrives in fast-paced environment.

Responsibilities Under supervision and in accordance with all applicable federal, state and local laws / regulations (including local / regional regulations outside US, as required), GCP / ICH guideline, and the Company’s policies, procedures, and guidelines, this position is responsible for the following :

• Participate in study team meetings (planned and / or on an ad hoc basis) ， support in the planning, organization, and follow-up of meetings as needed, and produce and track internal meeting agenda, minutes, and action items when necessary.
• Compile, distribute, collect (for some studies), and review for completeness, Investigator Initiation Packets and Regulatory Documents required for site initiation / investigational product release.  For some studies, create and maintain internal study activity trackers and study logs, (i.e., Study Site Start-up, Regulatory Documents, Monitoring Visit Trip Reports, Enrollment Logs, etc.).
• Review vendor / Investigator site documents / plans (e.g., monitoring plan) for legibility, typographical errors, and conformity to available source documentation (i.e., applicable SOPs, study protocol, etc.).
• For some studies, assist with start-up activities (i.e., development of informed consent and other study related documents).
• Create, file, track, QC, and archive the TMF, including filing and maintenance of electronic study files, as needed, as well as general study materials.
• Track the processing of Confidentiality, Consulting, and Study Agreements.   Powered by JazzHR