Responsible for writing and coordinating protocol submissions, amendments, progress reports,
final reports to the Institutional Review Board (IRB).
Responsible for coordinating submissions of Investigational Device Exemptions (IDE) and
Investigational New Drug (IND) protocols to the Food and Drug Administration (FDA).
Responsible for writing and coordinating annual progress reports, final reports, and all
correspondence with FDA in regards to all CRI-sponsored IDEs and INDs. Maintains database of
all CRI projects to insure that projects are in good standing with all related agencies.
Responsible for writing research-related informed consent forms.
Responsible for development of contract language and budget terms. Negotiates with sponsors to
reach mutually agreeable terms.
Responsible for tracking progress of all submissions to IRB and OCGM, providing updates to
investigators/coordinators and sponsors.
Provides instruction and feedback to investigators, nursing coordinators, and administrative
staff in submission and review of research protocols, continuations, terminations, and safety
reporting to the IRB.