Hiring: Clinical Researh Operation Coordinator Lead FSM/CC Company: Northwestern University Location: Chicago, IL Job Posted Time: 2026-09-15 11:29:30 Employment Type: Contract Target Skills & Keywords : GCP, HTML, Microsoft Office, Project Management, Quality Assurance About the job Required Skills: •Ensures completion of contract requirements & client specifications. •Lead and oversee 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. •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. •Organizes, plans, and controls work flow of the regulatory staff within the assigned teams and is responsible for ensuring clinical trials are conducted in compliance with federal, state and institutional guidelines. This position will provide significant input into the development of SOPs and training programs for clinical staff. •Anticipates and develops QA activities and processes related to electronic systems oversight based on risk. Develops staff to serve as QA representatives on assigned project teams to provide direction regarding quality and compliance, to communicate compliance issues to management and to oversee completion of quality related action items. •Organizes, plans, and controls work flow of the QA staff within the assigned teams and is responsible for ensuring clinical trials are conducted in compliance with federal, state and institutional guidelines. This position will provide significant input into the development of SOPs and training programs for clinical staff. Compensation: •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!