Working under the general direction of the Manager and/or Director, the Clinical Trial Associate is assigned to Alzheimer’s clinical research trials regulatory tasks. Clinical Trial Associates are primarily responsible for compliance with current regulations, policies, procedures, coordination regulatory documentation activities, IRB submissions, maintain master files (paper and electronic), liaison with the sponsor for startup and ongoing clinical trial activities.

Key Responsibilities

Clinical Trial Start-up Activities

• Prepare, compile, and submit regulatory packages to Sponsor/CRO and Ethics Committees/IRBs.
• Coordinate the collection and review of essential study documents, including clinical protocol, Investigator’s Brochure (IB), informed consent forms (ICFs), and site-level documentation.
• Ensure compliance with applicable regulations (e.g., ICH-GCP). Track submission status, support regulatory strategy, and collaborate w...