Senior Regulatory Compliance Officer – CCC | Clinical Trials Office

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position Summary

The Senior Regulatory Compliance Officer (RCO) for Cell Therapy will be responsible for regulatory affairs for oncology clinical trials and for the Cell Therapy Lab. Coordinates and prepares document packages for regulatory submissions, ensuring compliance with the Food and Drug Administration (FDA), Institutional Review Board (IRB), and Institutional Biosafety Committee (IBC); Reviews, evaluates, and compiles files and reports for submissions both for initial investigational new drug applications, protocol submissions, and annual reports; Collaborates with investigators during study development to facilitate and confirm that appropriate regulatory safeguards have been included; Conducts detailed reviews of assigned protocols and informed consent forms prior to IRB review; Communicates with all research projects sponsors (academic, federal, industry) to ensure compliance; Interfaces with various internal and external entities to coordinate and effectively compile all appropriate data relevant to the conduct of trials; Develops IRB submission packets for protocols, including writing of abstract, submission of standard forms and drafting of informed consent forms; Provides and maintains tracking system to assess progress of a protocol’s review; Maintains regulatory essential files on submitted and approved studies; Reviews all protocol revisions and amendments; Amends consent forms if needed and follows established guidelines to determine if amendments requires IRB review; Distributes all amendments and IRB approved informed consent forms and documents to relevant university protocol holders; Serves as principal contact from Cell Therapy Lab to regulatory agencies including FDA and IRBs; Continually monitors federal and sponsor rules, regulations and processes to identify and interpret new, updated or changed requirements; Participates in audits and site visits; Provides project team representation and direction in managing information from/to other groups in the OSUCCC Clinical Trials Office and Cell Therapy Lab (clinical research coordinator, Director of the Cell Therapy Lab, etc.) regarding regulatory submissions including the preparation of outlines, summaries, status reports, graphs, charts, tables and slides for distribution and communication to other departments; Reviews technical and clinical protocol documentation and recommends changes in clinical protocol for regulatory compliance; Researches and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registrations; Develops and maintains current regulatory knowledge and keeps abreast of regulatory procedures and changes; provides regulatory guidance to project teams and junior staff.

Job Requirements

Bachelors Degree in biological sciences, health sciences, social sciences or other medical field or an equivalent combination of education and experience required; Masters degree in a relevant field desired; 3 5 yrs. of experience in a clinical research or administrative capacity working on clinical research projects required; ACRP (Assn of Clinical Research Professionals) or SOCRA (Society of Clinical Research Associates) certification required; knowledge of clinical research regulations and compliance issues especially related to the use of human and animal subjects required; experience and knowledge of federal amp; industry research sponsor requirements preferred; experience in a regulatory affairs capacity in a medical research setting desired; experience in protocol development and strong writing skills desired.

 

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