Clinical Development Associate in NC-Chapel-Hill, United States

Employment Type: Permanent Staff (EHRA NF)

Vacancy ID: NF0008554

Salary Range: Salary commensurate with qualifications

Position Summary/Description:

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 ).

Education and Experience:

Experience and expertise in oncology research is highly desirable. Experience in grant writing.

Essential Skills:

Advanced clinical health science degree (i.e., Pharm.D. 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.

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.