Regulatory Coordinator, Senior for Chicago, IL location. Coordinate and guide the review and approval process of all research activities associated with complex clinical research studies involving human subjects ensuring the protection of their safety, rights and welfare. These studies are considered complex by the inclusion of several of the following: multiple investigators; teams; sites; sub-contracts; participants; longitudinal assessments/interventions; multi-million dollar budgets. Interpret and apply rules and recommend and guide principal investigators and research staff in the preparation, creation, submission, and maintenance of regulatory documentation and reporting of study activities ensuring appropriate protocol compliance, including informed consent process, modifications, amendments, safety reports, etc. Liaise between research staff and internal/external regulatory/oversight groups. Work with clinical data mining teams to derive regulatory components for FDA and IRB submissions. Represent Regulatory Department on NU-IIT team in planning and implementation of Phase I trials. Provide training and guidance to junior staff. Technical Environment: EMR/EPIC.
Qualifications: Bachelor’s degree in Health Administration plus three years of experience in the job offered or with clinical research protocols required. Required skills: 3 years of experience with each: protocol compliance; preparation & maintenance of regulatory documentation; informed consent process; clinical data mining. Criminal background check required.
As per Northwestern University policy, this position requires a criminal background check. Successful applicants will need to submit to a criminal background check prior to employment.
Northwestern University is an Equal Opportunity, Affirmative Action Employer of all protected classes, including veterans and individuals with disabilities. Women, racial and ethnic minorities, individuals with disabilities, and veterans are encouraged to apply. Hiring is contingent upon eligibility to work in the United States.
Northwestern University is a major private research university with 12 academic divisions located on three campuses in Evanston, Chicago, and Education City in Doha, Qatar. We have approximately 2,500 full-time faculty members, 17,000 graduate and undergraduate students, and over 5,700 full and part-time staff. Northwestern University combines innovative teaching and pioneering research in a highl...y collaborative environment. It provides students and faculty exceptional opportunities for intellectual, personal and professional growth.