Salary Range: Dependent on Education/Qualifications
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 Oncology Clinical Protocol Office (CPO) is primarily responsible for organizing, managing, conducting, and supporting these trials. The Senior Clinical Protocol Development Associate will serve as a consultant to investigators aiding in the development of strategic protocol designs by providing critical guidance including recommendations on alternative protocol designs, more efficienct ways to implement amendment amendments and innovative ways of streamlining trial logisitic. The position will provide continued support to development of the evolving clinicall protocol design. This position will collabroate with investigators in the medical writing and editing oncology clinical trial letters of intent (LOIs) and protocols and will perform quality assurance of protocols written by investigators or other clinical protocol development associates. The position will lead review meetings involving key clinical and correlative study stakeholders to ensure development of a high quality final product. The position will include project management of the investigator initiated clinical protocol portfolio including facilitating communication with strategic partners and performing proactive rview/screening of new IIT opportunities.The position will aid in the training of new investigators and the continued education of senior investigators on clinical protocol design/writing processes and current protocol development-related guidance from FDA, ASCO, NIH, NCI and other applicable external entities.
Education and Experience:
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 clinical study design, protocol development, and working knowledge of the following: federal and local regulations of clinical trials; drug development within the pharmaceutical industry; and bio statistics. Experience and expertise in oncology research is highly desirable. 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 supervisor.
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.
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