Regulatory Affairs Coordinator (EVERGREEN)

At Geneva, we are always on the search for top talent. While this role is not associated with a current opening, one may become available in the near future. Resumes are reviewed on an ongoing basis, and you could be contacted for this role or similar, at anytime.

About This Position

The Regulatory Affairs Coordinator maintains regulatory documents related to research, serves as principal administration regulatory liaison for projects, develops and maintains recordkeeping systems and procedures, supervises and prepares documents which support research projects, submits and manages IRB application documents, collate appropriate trainings, and provide regulatory audit support.

About The Project

This research takes a deep dive into the underlying physiology of warfighters with poor sleep quality or insomnia, with a focus on quantifying the sympathetic or "fight or flight" system.

Responsibilities

• Prepare and/or track Institutional Review Board (IRB) initial applications, continuing review submissions, annual reports, protocol amendments and addendums, review and edit protocols, and informed consents
• Prepare, negotiate, coordinate and track IRB review and documentation pertinent to the use of IRB reliance/master agreements for situations when performance sites rely on an IRB at another institution
• Prepare and file study binder, "notes to study file" and communications log/file
• File and maintain study case report forms
• Maintain Investigator Curriculum Vitae & license requirements and all other regulatory documents as necessary
• Maintain and report study subject tracking
• Promote safety and confidentiality of research participants at all times
• Act as coordinator for weekly research meeting, including updates of current and future research, minutes and reports as needed
• Provide administrative support to investigators and research staff as needed
• Monitor progress of research activities and develop and maintain records of research activities
• Ensure publicly released study information is approved by the Public Affairs Office
• Stays up-to-date in all relevant research training
• Maintain and update files of all applicable regulatory documentation (including protocols, approvals, amendments, modifications, etc.) as well as any communications with the sponsor or any other Federal or regulatory office (including prior approvals, change in scope, etc.)
  
  
  

Qualifications

• Bachelor’s degree or equivalent work experience required
• Regulatory and IRB submission experience required
• 2-4 years’ experience in clinical research experience preferred
• 2-4 years non-profit, research, or healthcare experience desired
• Demonstrate competence in oral and written communication
• Must be organized, strong attention to detail, and possess a positive, friendly and professional demeanor
• Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner
• Computer skills including at least intermediate level experience with Excel and other Microsoft Office Software
  
  
  

The Geneva Foundation is an equal opportunity employer and prohibits discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.