The Administrative Regulatory Coordinator will have a responsibility to ensure the integrity and accuracy of all regulatory documentation within the organization. This role will also demonstrate knowledge of Good Clinical Practices and FDA regulations specifically pertaining to the recruitment and retention of study subjects.

DUTIES & RESPONSIBILITIES

• Compile and prepare materials for submission to regulatory agencies
• Review clinical protocols to ensure collection of data needed for regulatory submissions
• Identify relevant guidance documents
• Assists Regulatory team with maintenance of electronic files in electronic regulatory binders (Florence)
• Assists Study Team in completing study documentation and maintenance of study files in accordance with sponsor requirements and internal policies and procedures including, but not limited to, study protocols, financial disclosure forms, FDA 1572 forms, study site logs and other essential documents.
• Perform regularly Quality Control reviews in electronic regulatory binders (Florence)
• Attend team meetings as required
• Other tasks as assigned by the line manager / supervisor

KNOWLEDGE & EXPERIENCE

Education:

• Bachelor's degree in Nursing, Public Health, Healthcare Administration or related scientific field require preferred, but not required

Experience:

• Minimum 6 months-1 years of experience in clinical research

Credentials:

• N/A

Knowledge and Skills:

• Clinical Research Industry and knowledge of clinical trials preferred.
• Considerable understanding of Good Clinical Practice (GCP) guidelines, Food & Drug Administration (FDA), Office of Human Research Protection (OHRP), and Health Insurance Portability & Accountability Act (HIPAA) regulations.
• Skill in time management, prioritization, and multitasking.
• Skill in writing and communicating effectively.
• Ability to work under pressure, communicate and present information
• Ability to multitask, establish priorities, and coordinate work activities.
• Ability to competently use Microsoft Office, including Word, PowerPoint,Excel, and Google Suite.
• Ability to work during US hours (Central Time 8:00AM-5:00PM)