Senior Research Regulatory Coordinator - RI Behav Trials Off

Nationwide Children's Hospital • Columbus, OH

4d

About The Position

Overview: The Behavioral Trials Office (BTO) partners with investigators to provide efficient coordination and regulatory support for diverse behaviorally focused clinical research, including behavioral intervention trials and observational studies. Our work spans multiple pediatric departments and developmental stages, supporting innovative research that improves child health outcomes. The Sr. Regulatory Coordinator plays a key role in this effort by providing regulatory oversight and support for multiple federally funded research studies. In addition, this role contributes to the development and implementation of regulatory and compliance training initiatives within the BTO, helping to ensure that research teams operate in accordance with institutional policies and federal regulations. Job Description Summary: 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) andof Investigational New Drug Applications (IND’s) to the U.S. Food and Drug Administration (FDA). Job Description: Essential Functions: 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.

Requirements

• Bachelor’s degree or equivalent experience in medical/science field.
• Two years Clinical Research Experience, required.
• Knowledge of medical terminology and diseases, preferred.
• 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

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level