Senior Research Regulatory Coordinator - RI Gene Ther

Nationwide Children's Hospital•Columbus, OH

20h

About The Position

Coordinates the regulatory and compliance process of all clinical research conducted in the NCH/RI system. Oversees the preparation and submission of regulatory and compliance documents to study sponsors and assists with quality improvement initiatives. Coordinates submissions of human subjects research project to the Institutional Review Board (IRB) and of Investigational New Drug Applications (IND’s) to the U.S. Food and Drug Administration (FDA).

Requirements

Bachelor’s degree or equivalent experience in medical/science field.
Two years Clinical Research Experience, required.
Excellent computer skills.
Ability to multi-task with strong organizational and prioritization skills.
Strong attention to detail.
Customer focused personality.
Working knowledge of IRB and regulatory processes and systems.
Current knowledge of Federal regulations (FDA, GCP, NIH, DHHS, ICH GCP), and study protocols.

Nice To Haves

Knowledge of medical terminology and diseases, preferred.
CCRP certification preferred.

Responsibilities

Reviews study protocols in order to write consent/assent documents and develop the initial IRB submission; submits protocol amendments; responds to contingencies and obtains final approval of documents from sponsor and IRB, on behalf of principal investigator.
Serves as liaison between study sponsors and the research team (IRB, research staff and Principal Investigator) regarding regulatory matters in the IRB submission and approval process.
Responsible for the preparation, submission and maintenance of documents and processes related to investigator-initiated drug/device projects.
Serves as liaison with federal agencies as needed.
Oversees the creation and maintenance of regulatory documents and the study administrative binder required for the clinical research project.
Maintains current knowledge of federal research regulations by reviewing current publications and attending conferences.
Advises management of regulation changes and projected impact within Clinical Research Services and the institution.
Primary resource to provide guidance to investigators and research staff on federal regulations, good clinical practices and IRB policies and systems.
Identifies protocol content which may conflict with federal and/or local requirements or practice.
Assists with quality improvement audits, including the administrative binder, subject research records, case report forms and other study documents.
Responsible for data required for CCTS annual report and other metrics as required.