Research Regulatory Coordinator - RI Gene Therapy

Nationwide Children's Hospital•Columbus, OH

About The Position

Assists with the administrative components required to ensure compliance in the regulatory processes for a clinical research project. Creates the initial study administrative binder required for the clinical research project. Maintains study binders, files documents timely, and reviews binders prior to monitor visits to ensure completeness. Prepares, submits, and maintains IRB related documents. Ensures accuracy and congruency between IRB, regulatory documents, study documents and grants system. Confirms all investigators, staff and departments to be used for the study. Collects CV’s and licenses and confirms that IRB training requirements have been met. Maintains master file of current CV’s and licenses. Collects and stores regulatory documents required by the clinical research project in compliance with federal and local regulations and guidelines. Keeps site documents up to date (IRB roster, lab certificates, etc.). Oversees document retrieval and archival process at study termination. Works with marketing and research staff to ensure studies utilizing recruitment tactics are posted appropriately.

Requirements

Associates degree or equivalent experience in medical/science field.
Strong administrative skills and attention to detail.
Excellent computer skills.
Knowledge of medical terminology and diseases.
Ability to multi-task; customer focused personality with strong organizational and prioritization skills.
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

Six months research experience, preferred.

Responsibilities

Creates the initial study administrative binder required for the clinical research project.
Maintains study binders, files documents timely, and reviews binders prior to monitor visits to ensure completeness.
Prepares, submits, and maintains IRB related documents.
Ensures accuracy and congruency between IRB, regulatory documents, study documents and grants system.
Confirm all investigators, staff and departments to be used for the study.
Collects CV’s and licenses and confirms that IRB training requirements have been met.
Maintains master file of current CV’s and licenses.
Collects and stores regulatory documents required by the clinical research project in compliance with federal and local regulations and guidelines.
Keeps site documents up to date (IRB roster, lab certificates, etc.).
Oversees document retrieval and archival process at study termination.
Works with marketing and research staff to ensure studies utilizing recruitment tactics are posted appropriately.