Specialist-Research Regulatory

Work Shift/Schedule: 10 Hr Morning - Afternoon Northeast Georgia Health System is rooted in a foundation of improving the health of our communities. About the Role: 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. Minimum Job Qualifications Licensure or other certifications: Educational Requirements: Bachelors Degree in a Scientific discipline or equivalent. Minimum Experience: Education and/or experience in a healthcare related field and one (1) year experience in clinical research and regulatory procedures is strongly desired. Other: Preferred Job Qualifications Preferred Licensure or other certifications: Preferred Educational Requirements: Preferred Experience: Specialized training/certification in Regulatory Affairs or Clinical Research. Other: 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). Physical Demands Weight Lifted: Up to 20 lbs, Occasionally 0-30% of time Weight Carried: Up to 20 lbs, Occasionally 0-30% of time Vision: Heavy, Constantly 66-100% of time Kneeling/Stooping/Bending: Occasionally 0-30% Standing/Walking: Occasionally 0-30% Pushing/Pulling: Occasionally 0-30% Intensity of Work: Occasionally 0-30% Job Requires: Reading, Writing, Reasoning, Talking, Keyboarding, Driving Working at NGHS means being part of something special: a team invested in you as a person, an employee, and in helping you reach your goals. NGHS: Opportunities start here. Northeast Georgia Health System is an Equal Opportunity Employer and will not tolerate discrimination in employment on the basis of race, color, age, sex, sexual orientation, gender identity or expression, religion, disability, ethnicity, national origin, marital status, protected veteran status, genetic information, or any other legally protected classification or status. Opened in 1951, Northeast Georgia Health System (NGHS) is a non-profit community health system on a mission of improving the health of our community in all we do. Our team cares for more than 1 million people across the region through four hospitals and a variety of outpatient locations. Northeast Georgia Medical Center (NGMC) has campuses in Gainesville, Braselton, Winder and Dahlonega – with a total of more than 700 beds and more than 1,100 medical staff members representing more than 50 specialties. NGHS also encompasses Northeast Georgia Physicians Group, a multi-specialty group with more than 65 locations, and The Heart Center of Northeast Georgia Medical Center, a cardiology practice with more than 15 locations.