Regulatory Specialist for Clinical Trials

Join as a Clinical Trial Associate to ensure compliance in Alzheimer’s clinical trials. This role requires expertise in regulatory documentation and managing essential study documents in a collaborative on-site role.
In this pivotal role, you will report to the Manager/Director and assist in regulatory tasks essential to Alzheimer’s research trials. Your key functions will include compiling and submitting regulatory packages, maintaining documentation, and coordinating with both internal and external stakeholders. Effective communication and organizational competencies will be essential to your success.
Key Responsibilities:
• Compile and submit regulatory packages to Sponsors and IRBs
• Track the submission status and manage ongoing amendments
• Ensure Investigator Site Files maintain compliance
• Serve as the point of contact for assigned studies
• Oversee internal team training and compliance tracking
Requirements:
• At least 2 years in a relevant regulato...