Clinical Research Regulatory Affairs Specialist

3 weeks ago


Philadelphia, Pennsylvania, United States DirectEmployers Full time
Job Summary:

The Clinical Research Regulatory Specialist will be responsible for maintaining regulatory compliance for the Department of Otorhinolaryngology. This role will provide regulatory support and expertise associated with clinical trials, working with a diverse group of investigators and coordinators involved in a broad spectrum of clinical trials.

Key Responsibilities:

• Prepare and process all regulatory documentation through the IRB, CTSRMC, and other applicable regulatory review committees.
• Prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), and other entities.
• Organize and maintain all regulatory affairs documentation/files as needed.
• Resolve regulatory and data queries as required and participate in initiation, monitoring, audit, and close-out visits.
• Participate in study team meetings, research team meetings, and ongoing protocol training/compliance meetings.
• Facilitate the development of grant and clinical trial submission of applications and annual reports.
• Provide direct regulatory/compliance guidance and facilitate investigator-initiated multi-site trials.

Requirements:

A High School diploma and 2 years of experience or an equivalent combination of education and experience are required. A bachelor's degree is preferred. The position is contingent on continued funding.

Working Conditions:

The position will be based in an office environment with occasional lifting of 25 lb. or less. The position requires extensive safety precautions and adherence to regulatory guidelines.

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