Clinical Development Associate

The UNC Lineberger Comprehensive Cancer Center (LCCC) oversees and coordinates oncology clinical trial research for the UNC School of Medicine and UNC Cancer Care. The UNC Lineberger Sponsored Clinical Research team is primarily responsible for the clinical development, regulatory strategic management and FDA interactions for these LCCC sponsored trials. This position will provide strategic and tactical leadership to UNC investigators in support of their interdisciplinary drug / biologic clinical and translational protocol development and regulatory submissions. This position will collaborate in writing, editing, producing and reviewing clinical and / or translational oncology clinical trials protocols. This position will author strategic amendments to clinical protocols. This individual will aid in the authoring of LOIs (letters of intent) and development of grants to support these clinical and translational protocols. The individual will aid in the preparation of Investigational New Drug (IND) serial submissions and responding to queries from the Food and Drug Administration (FDA). Minimum Education and Experience Requirements Relevant post-Baccalaureate degree required (or foreign degree equivalent); for candidates demonstrating comparable independent research productivity, will accept a relevant Bachelor’s degree (or foreign degree equivalent) and 3 or more years of relevant experience in substitution. May require terminal degree and licensure. Required Qualifications, Competencies, and Experience Advanced clinical health science degree MSN, NP, MD) or PhD. Possess excellent written and oral communication skills, interpersonal skills, and be comfortable interacting with individuals at all levels internal and external to UNC Lineberger. Have a strong record of experience in medical writing or protocol writing and working knowledge of the following : federal and local regulations of clinical trials; drug development; and bio statistics. Candidate must enjoy working collaboratively with multidisciplinary groups of colleagues. Must be able to manage multiple projects at various stages and be able to work independently with occasional guidance from physician leadership or management. Significant information technology is expected for this position. Preferred Qualifications, Competencies, and Experience Experience and expertise in oncology research is highly desirable. Experience in grant writing. Special Physical / Mental Requirements Campus Security Authority Responsibilities