Regulatory Affairs Coordinator Job at THE GENEVA FOUNDATION (Bethesda)

Job Description

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. 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.

Job Responsibility

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.)

Requirements

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

What we offer

medical, dental, and vision healthcare
Flexible Spending Account
Health Savings account, with employer contribution
Coverage is provided for employees and family members including domestic partners
Short-and long-term disability
Employee Assistance Program
Life & ADD insurance
403b retirement plan with generous employer match
flexible leave options
11 paid holidays per year
up to 4 weeks of paid time off in a rolling year
Employees may qualify for PSLF as Geneva is a 501(c)(3) nonprofit organization

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