Job Description

• This position reports to the Clinical Operation Director, responsible for monitoring the execution of clinical studies to ensure compliance, quality, and timeliness. The CRA will work closely with the clinical research team to ensure all clinical study activities adhere to GCP, ICH, and company policies.

• Bachelor's degree in a related field or equivalent years of direct pharmaceutical industry experience.

• At least 5 years of pharmaceutical industry experience.

• Excellent oral and written communication skills.
• Ability to work effectively in cross-functional teams.
• Willingness to adapt to changing priorities and assignments.
• Proficiency in Microsoft Office Suite, including Word, Excel, PowerPoint, etc.
• Efficient, organized, and capable of multitasking.
• Familiarity with GCP standards, ICH guidelines, and federal regulations.
• Process-oriented with a strong attention to detail.
• Self-motivated and thrives in a fast-paced environment.
• Strong sense of responsibility and teamwork.

• Under all applicable federal, state, and local laws/regulations (including local/regional regulations outside the US, as required), GCP/ICH guidelines, and company policies, procedures, and guidelines, this position is responsible for the following:
• Participate in study team meetings (planned and/or ad hoc), support in the planning, organization, and follow-up of meetings as needed, and produce and track internal meeting agendas, minutes, and action items when necessary.
• Monitor study sites to ensure compliance with study documentation and procedures.
• Collect, review, and organize regulatory documents and study-related files from study sites.
• Assist in resolving issues at study sites and communicate solutions to the clinical research team.
• Track study progress to ensure timely and quality completion.
• Monitor the storage, distribution, and return of study medications and devices for compliance.
• Assist in preparing and submitting reports and documents to regulatory authorities.
• Maintain clinical study-related documents to ensure completeness and accuracy.

Policies and Procedures

• Ensure study compliance to Gan & Lee Pharmaceuticals, USA quality standards/processes and GCPs
• Performs other duties as required

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