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Research Regulatory Specialist
3 months ago
Research Regulatory Specialist page is loaded
Research Regulatory Specialist
Apply
locations
Gainesville, GA
time type
Full time
posted on
Posted Yesterday
job requisition id
R10889
Job Category:
Research & Research Administration
Work Shift/Schedule:
8 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.
About Us
Northeast Georgia Health System (NGHS) is a non-profit 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 five hospitals and a variety of outpatient locations. Northeast Georgia Medical Center (NGMC) has campuses in Gainesville, Braselton, Winder, Dahlonega and Demorest – with a total of more than 850 beds and more than 1,200 medical staff members representing more than 60 specialties. Learn more at www.nghs.com .
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