"IND Lead"

Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation's top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UC Irvine has more than 36,000 students and offers 224 degree programs. It's located in one of the world's safest and most economically vibrant communities and is Orange County's second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide. To learn more about UC Irvine, visit www.uci.edu.

The UCI Alpha Clinic coordinates all the Cell and Gene Therapy Clinical Trial activities at UCI, including the submission of IND packages and the implementation of first-in-human clinical trials. The goals of this IND unit include assisting faculty with writing IND modules, as well as clinical trial protocols to ensure successful submissions and amendments.

The Clinical Research Development Specialist will report to the Director and the Assistant Director of the UCI Alpha Clinic. This position works closely with School of Medicine faculty, residents, and fellows to assist them with writing IND modules, as well as clinical trial protocols to ensure successful submissions and amendments. This position works with the primary author to ensure stylistic conformity, logical organization of text, and rational development of the scientific argument, and embraces project management skills to ensure that all components are optimal prior to submission.

Required: Thorough understanding of research administration guidelines of Federal and non-Federal sponsors supporting research and educational activities, preferably in a university environment. Thorough knowledge of applicable compliance requirements related to use of human or animal subjects in research, financial conflict of interest, biosafety, etc. Ability to manage a significant volume of transactions. Ability to maintain independent judgment; strong organization and communication skills; and a customer service focus across broad and diverse subject areas. Maintains current knowledge of compliance regulations in all areas of research administration. Strong writing skills in a variety of styles to draft persuasive text for a variety of audiences while ensuring adherence to funding sponsor guidelines. Strong oral and written communication skills. Strong ability to think creatively and independently on concepts requiring advanced analytical skills. Strong interpersonal skills and the ability to work with diverse groups to achieve results. Strong ability to work collaboratively with internal and external peers, managers, and teams. Proven program planning and management of projects. Bachelor's degree in related area and / or equivalent experience / training. A minimum of 1 year of experience. Academic background and experience in the selected area of research required.

Preferred: Ability to perform complex financial analysis and customized reporting. Demonstrated competence in the use of spreadsheet and database software in financial analysis, fiscal management, and financial reports. Demonstrated knowledge of generally accepted accounting, fiscal, and reporting principles. Demonstrated knowledge of effective grant funding processes, procedures, and techniques. Academic or industry experience in successfully writing grants and protocols and obtaining funding is preferred.

In addition to the salary range listed below, we offer a wealth of benefits to make working at UCI even more rewarding. These benefits may include medical insurance, sick and vacation time, retirement savings plans, and access to a number of discounts and perks. Please utilize the links listed here to learn more about our compensation practices and benefits.