CTA

Summary

This position reports to the 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.

• College degree in relevant field or equivalent years of direct industry related experience.

• At least 3 - 8 years of industry experience.

• Must have good communication skills (both oral and written).
• Ability to work in a 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 a fast‑paced environment.

• Participate in study team meetings (planned and/or on an ad hoc basis), support 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.