CTA

This position reports to the Clinical Operation Director at Gan & Lee Pharmaceuticals USA Corporation or designee. The role involves working closely with the Clinical Operations Team to assist with the day-to-day management of clinical studies.

• College degree in a relevant field or equivalent industry-related experience.

• At least 3 to 8 years of industry experience.

• Excellent communication skills (both oral and written).
• Ability to work effectively in a cross-functional team.
• Willingness to adapt to changing priorities and assignments.
• Proficiency with Microsoft Office Suite (Word, Excel, Project, PowerPoint).
• Organized, efficient, and capable of multitasking.
• Knowledge of GCP standards, ICH guidelines, and Federal Regulations.
• Process-oriented with strong attention to detail.
• Self-motivated and proactive.
• Team player who thrives in a fast-paced environment.

Under supervision and in compliance with all applicable laws, regulations, GCP/ICH guidelines, and company policies, the responsibilities include:

• Participating in study team meetings, supporting planning, organization, and follow-up, and documenting actions.
• Compiling, distributing, and reviewing Investigator Initiation Packets and Regulatory Documents for study site initiation and investigational product release.
• Creating and maintaining study activity trackers and logs, such as Study Site Start-up, Regulatory Documents, Monitoring Visit Trip Reports, and Enrollment Logs.
• Reviewing vendor and investigator site documents for accuracy and compliance.
• Assisting with start-up activities, including development of informed consent and related documents.
• Managing the Trial Master File (TMF), including filing, tracking, quality control, and archiving.
• Tracking the processing of Confidentiality, Consulting, and Study Agreements.