Apply on Employer Site

The Geneva Foundation · 1 day ago

Regulatory Affairs Coordinator (EVERGREEN)

Bethesda, MD

Full-time

Onsite

Entry, Mid Level

$65K/yr - $75K/yr

2+ years exp

The Geneva Foundation is always on the search for top talent, seeking to fill the role of Regulatory Affairs Coordinator. This position involves maintaining regulatory documents related to research, serving as the principal administration regulatory liaison for projects, and managing IRB application documents.

Clinical TrialsEducationNon Profit

No H1B

Security Clearance Required

U.S. Citizen Only

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.)

Qualification

Regulatory submission experienceClinical research experienceMicrosoft Office proficiencyProfessional demeanorOral communicationWritten communicationAttention to detailOrganizational skillsFlexibility