The Clinical/Social Research Assistant reports directly to the Clinical/Social Research Specialist. The primary purpose of this position is to assist the Clinical/Social Research Specialist with the regulatory aspects of consortium research studies (initial IRB submissions, continuing reviews and protocol amendments), enrollment of study patients, patient registration, as well as study management including data abstraction & entry, lab processing & shipping, and creation of shadow study charts. The Clinical/Social Research Assistant will assist with the Children's Oncology Group (COG) Industry studies, COG non-Industry studies, New Approaches to Neuroblastoma Therapy (NANT) studies, and other clinical trials within the PHO Division.
Selected candidate should be able to transcribe data accurately into the appropriate data capture forms/database in a timely fashion per the clinical trials agreement; selected candidate must also be able to assist in initiating, maintaining and updating all protocols with central and local IRBs and minting the appropriate regulatory documents.
Education and Experience:
Bachelor’s degree; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.
The candidate should have excellent verbal and written communication skills with ability to interact with clinical investigators, laboratory personnel, study sponsors, IRB, Office of Clinical Trials, and support staff. Working knowledge of medical terminology, techniques and methodologies used in developing, coordinating and managing clinical research projects. Applicant must have a working knowledge of FDA Code of Federal Regulations (CFR) and International Conference on Harmonisation Good Clinical Practice (ICHGCP) as well as familiarity with local, state and federal guidelines governing clinical trials. Applicant should have a working knowledge of database management and spreadsheets. Ability to learn quickly, work independently and efficiently with minimal supervision, prioritize tasks, and work under deadline pressure. Flexibility is required for intermittent evening and weekend hours as needed for patient enrollment after normal business hours.
It is strongly preferred that the selected candidate have a license to practice as a registered nurse in the state of North Carolina with Pediatric Oncology experience; graduated from a state accredited school of professional nursing. Experience with clinical research (including the UNCIRB processes, FDA regulatory requirements, ICHGCP guidelines, ACRP or SOCRA certification) is strongly desired. Pediatric Oncology experience and familiarity with Children's Oncology Group preferred. Candidate should have an understanding of medical terminology with the ability to extract information and summarize patient data.
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.
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.