Regulatory Affairs Coordinator (Evergreen) at The Geneva Foundation – United States
Recruiter: The Geneva Foundation
About The Geneva Foundation
The Geneva Foundation is a non-profit organization that promotes and supports innovative medical research and education within the U.S. military medical community to benefit U.S. service members and their families.
Job Summary
This position offers an opportunity to contribute to administrative management within The Geneva Foundation’s important work in international cooperation and sustainable development. Working in United States, you will collaborate with international colleagues and partners to address global challenges and promote sustainable development. This role provides an excellent opportunity for professional growth while making a meaningful contribution to international cooperation and global peace and security.
Full Job Description
QUALIFICATIONS
Bachelors 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
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.)
Key Details
- Job Title: Regulatory Affairs Coordinator (EVERGREEN)
- Grade: N/A
- Location: Bethesda, United States
- Department: The Geneva Foundation
- Contract Type: Professional Staff
- Estimated Salary Range:$84,000 – $144,000 USD annually
Qualifications
- Not specified in the official posting
Skills
- Not specified in the official posting
Benefits
- Competitive compensation package
- Professional development opportunities
- Comprehensive health and wellness benefits
- Inclusive and collaborative work environment
How to Apply
Applications must be submitted through the official UN careers portal. Female candidates and candidates from underrepresented groups are strongly encouraged to apply.