Regulatory Associate Lead | The University of North Carolina at Chapel Hill - Military Veterans

Employment Type: Permanent Staff (EHRA NF) Vacancy ID: NF0008486 Salary Range: Dependent on Qualifications/Experience Position Summary/Description: The purpose of the Regulatory Associate Lead is to facilitate the conduct of oncology clinical trials by ensuring regulatory compliance with federal regulations, Good Clinical Practice, and local and institutional policies. In particular, this position is responsible for: * Assisting Regulatory Management by providing managerial support, including reviewing promptly reportable information reports to the IRB , participating in interviews of Regulatory applicants, monitoring trends in actions items/findings from monitoring letters and audit reports, attending pre-study team regulatory meetings, and signing off on timecards for Regulatory staff * Taking a lead role in activation of new oncology clinical trials, including preparing and submitting regulatory documents for new studies to the IRB and ancillary committees, as well as monitoring and assisting with activation activities performed by other Regulatory staff * Assisting with Regulatory training, including drafting standard operating procedures and work instructions, preparing and leading trainings for Regulatory staff, and participating on CTO committee and working groups * Preparing, submitting, and processing regulatory applications, forms and documents required to conduct clinical research at UNC LCCC to the to the IRB and ancillary committees * Preparing informed consent forms, HIPAA documents, and participant materials * Ensuring regulatory compliance for assigned disease groups, including timely and accurate reporting of unanticipated problems and noncompliance events to the IRB , contributing to development of CAPAs and root causes analyses for non-compliance events, and preparing for monitoring and audit visit and responding to action items and findings * Assisting with the maintenance of the regulatory binder, including entering regulatory and study information in the electronic clinical trial management system (OnCore) and eRegulatory binder (Florence). These responsibilities relate to the UNC / LCCC CTO 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: Experience preparing and maintaining IRB applications, including initial, continuing review, amendment modification, and expedited report submissions, for: - therapeutic clinical research studies involving a drug or device, and/or - oncology clinical research studies Experience preparing submissions to ancillary committees, such as the Protocol Review Committee, Institutional Biosafety Committee, Investigational Drug Services, Radiation Safety Subcommittee. SOCRA , RAC , or ACRP certification preferred Project management experience Essential Skills: Demonstrated experience in clinical research, including advanced knowledge of 21 CFR Parts 50, 54, 56, 312, 314, 812 and ICH GCP Guidelines. Demonstrated experience using an eRegulatory system Possess strong decision-making skills and the ability to problem solve and troubleshoot issues High level of accuracy and attention to detail Demonstrated experience preparing and submitting accurate and complete IRB submissions, including initial and maintenance submissions, for complex treatment and nontreatment trials. Demonstrated ability to write standard operating procedures and prepare and lead trainings Demonstrated experience providing consultation and leading discussions regarding regulatory actions and compliance. Solid writing skills and experience preparing comprehensive reports Demonstrated ability to plan work to meet objectives and deadlines. Demonstrated ability to communicate effectively and professionally verbally and in writing Strong computer skills, including working knowledge and facility with Outlook, Word, Excel, and PowerPoint. Ability to sit for extended periods of time. Ability to work on evenings, weekends and/or holidays occasionally required. A cover letter is required as an example of professional written communication skills. AA/EEO Statement: 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, national origin, race, religion, sex, sexual orientation, or status as a protected veteran.