Previous experience in Clinical Research, and Good Clinical Practice required, as is a good understanding or experience with running Clinical Trials. Knowledge of pivotal submissions to the FDA (FDA or FDA CVM) is desirable. The ability to independently collect data and maintain accurate records in both written and digital form is essential, as is the ability to instruct others on doing this. The position requires the ability to support, develop, design, and/or execute moderately complex research activities for numerous research projects under the general guidance of multiple Principal Investigators. These activities will include budget development for grants and participation in formulating research methods by suggesting options for improving quality of study designs and recommending solutions for efficient and effective data collection. The ability to work with a variety of species of animals and to communicate effectively with clients whose pets are participating in trials is essential.
The position will involve the day-to-day organizational management and supervision of other CSC personnel (technicians).
Routine tasks will include the processing of clinical research applications, constructing budgets for plans of work, tracking time spent on individual projects, assisting with the generation of study documents (timeline, patient folders etc…), using and developing electronic data capture capabilities, assisting with Institutional Animal Care and Use Committee applications, recruitment of patients, scheduling clinical research patients, collecting biological samples from patients, and coordinating multiple schedules to allow for optimal flow of clinical studies, coordinating and scheduling patient visits and re-visits.
Tasks may also include design, developing and optimization of SOPs, extraction of DNA, RNA from biological specimens, maintain the database for the Biospecimen Respository, interfacing with potential or actual sponsors (Industry; Donors), laboratory maintenance, maintenance of safety plans.
NC State University is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, gender identity, age, sexual orientation, genetic information, status as an individual with a disability, or status as a protected veteran.
Individuals with disabilities requiring disability-related accommodations in the application and interview process, please call 919-515-3148.
Final candidates are subject to criminal & sex offender background checks. Some vacancies also require credit or motor vehicle checks. If highest degree is from an institution outside of the U.S., final candidates are required to have their degree verified at www.wes.org. Degree must be obtained prior to start date.
NC State University participates in E-Verify. Federal law requires all employers to verify the identity and employment eligibility of all persons hired to work in the United States.