Research Regulatory Specialist

at  Northeast Georgia Health System

JOB SUMMARY

The Research Regulatory Specialist performs a wide range of tasks essential to the submission, approval, and maintenance of required regulatory documents for conducting clinical research in compliance with the Federal Food and Drug Administration (FDA).
This position assures that all requirements are met for internal and external oversight bodies including, but not limited to, OHRP, DHHS, the Food and Drug Administration (FDA), the National Cancer Institute (NCI), Cooperative Groups, pharmaceutical & industry sponsors, IRB of Record and/or Central IRB (if applicable), and NGMC Research Committees.

PREFERRED EDUCATIONAL REQUIREMENTS:

• Preferred Experience: Specialized training/certification in Regulatory Affairs or Clinical Research.

JOB SPECIFIC AND UNIQUE KNOWLEDGE, SKILLS AND ABILITIES

• Must possess excellent written/editorial, interpersonal, verbal communications and computer literacy skills
• Communicate technical information in a clear, concise manner
• Compose letters/memorandums; coordinate meetings; proofread documents, research information; prepare reports; manage projects use computer systems; use team-building skills
• Foster and promote a positive departmental image by ensuring regulatory documents are accessible and organized
• Knowledge of Microsoft Office, EMR and CTMS systems preferred
• General knowledge of medical terminology preferred
• Must function well and communicate effectively as a member of a team
• Must be self-directed, resourceful, and uses a high degree of independent judgment and discretion

ESSENTIAL TASKS AND RESPONSIBILITIES

• Completes in a timely manner, the submission of all documents to the IRB required for the initial application of new studies and the annual renewal of current studies. Such documents include, but not limited to, FDA Form 1572, Financial Disclosures, Protocol Signature Page, Investigational Brochure and other documents required. Develops, implements, and evaluates data and time management processes to meet compliance guidelines and data submission deadlines for regulatory bodies and protocol sponsors. Accurate and timely compliance with protocol and regulatory requirements. Communicates routinely to the research staff about protocol updates and regulatory changes by updating the CTMS or by other appropriate methods. Reviews research studies offered by appropriate sources to help determine if studies are consistent with the department’s goals / objectives and patient population. Evaluates studies to determine and make recommendations about the level of engagement of NGMC, HSR, and IRB requirements (ex: exempt, expedited, full-board review).
• Actively participates in the development, implementation, monitoring, and regulatory oversight of high quality research within the department. Familiarity with clinical trials operations, finance, budgets, contracting and billing. Knowledge of Medicare, Medicaid, and/or commercial payer guidelines. Provides ongoing education and updates to physicians, nurses and other health professionals regarding protocol activities, including subject eligibility criteria, updates on new studies, amendments, closures, and other guidance. Assumes an active role during an audit to assure compliance with the regulatory component of the audit. Communicates new informational updates on clinical trials to investigators and staff in a timely and complete manner by updating the CTMS or by other appropriate methods. Routinely identifies methods that facilitate investigator compliance. Maintains information for Adverse Event and External Safety Reports for submission to the IRB, protocol sponsor, in compliance with the FDA and IRB policies. Maintains records (e.g., training certification, CVs, etc.) according to established department policies, procedures, and sponsor requirements. Participates in the development, review, and maintenance of clinical research policies and standard operating procedures (SOPS).