The Regulatory Associate is responsible for regulatory compliance of an assigned disease group(s) which includes providing regulatory guidance and training to investigators and CPO staff; preparing and submitting required regulatory documents and responses to regulatory bodies (e.g., Institutional Review Boards (IRB)); and creating and maintaining professional working relationships with investigators, sponsors, team members, and others. These responsibilities relate to the UNC/LCCCCPO mission by maintaining the quality of research and by addressing patient safety and regulatory compliance which impact on research quality and safeguarding institutional integrity.
Education and Experience:
Bachelor’s degree in a discipline related to the field assigned and one year of related training or experience; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.
Demonstrated ability to provide consultation and lead exchange of research information through technical assistance and instruction. Demonstrated ability to train others, including documenting steps needed to collect information and to independently provide consultation to sites or others related to the specific protocols and regulatory guidance. Demonstrated ability to write comprehensive reports summarizing results and conveying to supervisory personnel. Demonstrated ability to plan work to meet objectives and deadlines.
Significant use of information technology is expected for this position. Experience in clinical research preferred, including familiarity with CFR Parts 50, 54, 56, 312, 314 and ICH Guidelines. CCRP, CCRC, CIRB or RAC Certification preferred. A cover letter is encouraged as an example of professional written communication skills. Master's degree or higher preferred. CCRP, CCRC, CIRB or RAC Certification preferred.
The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, race, national origin, religion, sex, sexual orientation, or status as a protected veteran.
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