at Northwestern University in Evanston, Illinois, United States
Job Description
Job Opening Id: 49504
Department: MED-Cancer Center
Salary/Grade: EXS/9
Job Summary:
Clinical Focus:
This position provides clinical operational management oversight for multiple operations managers of the Cancer Center Clinical Trials Office (CTO). Manages all activities associated with biomedical &/or social-behavioral research studies considered very complex by the inclusion of several of the following: multiple investigators, teams, sites, sub-contracts, participants, longitudinal assessments/ interventions; &/or multi-million dollar budgets. Ensures completion of contract requirements & client specifications. Responsible for management, administration, organization and conduct of the clinical trials operations. Oversees day-to-day operations including assigning and supervising study staff to disease teams, identifying & securing needed resources, identifying the need for process improvement and developing and implementing plans. Provides leadership, training, coaching and mentoring of clinical operation supervisors and staff. Works collaboratively with operational leaders of the CC Finance, IT and other Medical School and Hospital units and departments engaged in clinical research.
Regulatory Focus:
Defines and implements regulatory strategies and priorities in conjunction with Director of Research Integrity and Compliance. Ensures application of established policies and best practice regulatory standards across network regions for all filings, maintenance of existing trial registrations and agency interactions.
May serve as primary regulatory contact with for FDA inspections. Assists Regulatory staff by outlining regulatory strategy and providing data needed to support filings, responses to Health Authorities inquiries, and trial registration maintenance. Oversees the regulatory workforce activities associated with highly complex biomedical &/or social-behavioral research studies including Investigator Initiated Trials, National Cooperative Group Trials with multiple affiliate institutions, and global Sponsored Trials.
