The primary purpose of this position will be to prepare submissions to IRB and other regulatory bodies including external IRBs, FDA and NIH, and communicate with staff, sponsors, and monitors regarding regulatory issues for clinical trial protocols, including multicenter and IND studies. This person will work within the regulatory department of the Institute for Global Health and Infectious Diseases ongoing clinical research studies. Main responsibilities include: - Perform independent and dependable work in preparation and coordination of study submissions to IRB (UNC ethics board) and other appropriate committees following regular deadlines; - Communicate with study staff, IRB, sponsors, domestic and international study partners in a courteous and professional manner; - Meet with study sponsor representatives as needed; - Prepare informed consent forms that follow appropriate regulations and meet sponsor requirements; - Address queries and memos from IRB and other regulatory authorities, prepare clinicaltrial.gov submission; - Maintain and organize electronic and paper regulatory documents and study files; - Perform Quality Assurance/Quality Control of study files; - Track and enter regulatory submissions using an electronic database, prepare reports using a database; - Participate in guideline development as appropriate, streamline processes; - Aid in training of study staff on regulatory procedures and compliance issues, adverse events, and protocol deviations; - Communicate potential issues to regulatory supervisor, study team members, investigators; - Assist other staff members in completion of work in a team-oriented fashion; - Complete other regulatory duties as assigned.
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.
Carolina rates among the nation’s great institutions of higher education, set on an historic and beautiful campus that celebrates all four seasons. Carolina’s students, faculty and staff come here from around the world, bringing varied cultural, racial and ethnic heritages that help make UNC-Chapel Hill a thriving intellectual center. We’re repeatedly ranked the nation’s best value in higher education for students seeking to earn a college degree – the University has garnered the top spot each time since the ranking’s launch in 1998.Whether you’ve just started your career, are new to academia or are a seasoned professional with assorted campus experiences to draw on, we hope you will find a great place at Carolina.