Regulatory Affairs Coordinator – Evergreen
The Geneva Foundation
full-time
Posted on:
Location Type: Office
Location: Bethesda • Maryland • United States
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Salary
💰 $65,000 - $75,000 per year
About the role
- Maintain regulatory documents related to research
- Serve as principal administration regulatory liaison for projects
- Develop and maintain recordkeeping systems and procedures
- Supervise and prepare documents which support research projects
- Submit and manage IRB application documents
- Collate appropriate trainings
- Provide regulatory audit support
- 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
- Stay 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
Benefits
- medical, dental, and vision healthcare
- Flexible Spending Account
- Health Savings account, with employer contribution
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory document maintenancerecordkeeping systemsIRB application managementprotocol reviewinformed consent editingstudy subject trackingresearch activity monitoringsafety and confidentiality promotionadministrative support in researchclinical research experience
Soft skills
oral communicationwritten communicationorganizational skillsattention to detailpositive demeanorflexibilitydiplomatic communicationprofessionalism
Certifications
Bachelor's degree