For UNC Office of Clinical Trials
DESCRIPTIONS OF ORGANIZATION: Before a drug, device or biologic can be prescribed by a physician for human use, the product must undergo stringent testing in humans, e.g., a clinical trial. The process of conducting clinical trials is governed by state and federal law and related guidelines. Human subject participation in clinical trials occurs in a variety of settings, including academic medical centers. OCT enters into contractual agreements on behalf of UNC-CH with pharmaceutical companies and other for-profit organizations involved in clinical trials. OCT reviews proposed language in contracts and negotiates terms including but not limited to intellectual property rights, indemnification, confidentiality obligations, and University rights to publish data. Types of agreements include clinical trial, non-disclosure and research agreements, and incoming and outgoing subcontracts for federally funded clinical research, among others. The director of OCT has been delegated signature authority on behalf of the chancellor of the University to obligate the University.
DESCRIPTION OF STUDENT WORK/PROJECTS: Review and comment on clinical trial agreement proposed terms, review and negotiate non-disclosure agreements, research emerging state and federal legislation affecting clinical trials, assist with development of faculty manual for investigator initiated research with a focus on the legal obligations as outlined in the Food and Drug Administration (FDA) guidelines.
COURSE OR OTHER REQUIREMENTS/PREFERENCES FOR STUDENT: Applicants should have a strong interest in law and medicine/health care/research, and the legal protection of the rights of human subjects. No certification required.