Associate Director Research Operations

Insight Hospital and Medical Center Chicago Research Department

Associate Director, Research Operations Title: Associate Director – Research Operations Location: Chicago Reports To: Director of Research Operations

Full-time remote (Home), with flexibility for study visits, sponsor meetings, and operational needs

The Associate Director of Research Operations is responsible for supporting Insight Hospital and Medical Center Chicago. This role is 50% focused on clinical Trials operations oversight and 50% dedicated to central feasibility, start up, regulatory, contracts and budgets, and quality functions. The Associate Director ensures operational excellence, compliance, and efficient execution of research activities across the network.

Key

• Clinical Operations Leadership (50%):
• Oversee clinical research operations
• Support site managers, team leads, coordinators, assistants, and investigators to ensure protocol adherence and visit execution
• Monitor enrollment performance, visit scheduling, and resource allocation
• Troubleshoot operational barriers and implement workflow improvements
• Support onboarding, training, and competency development for research staff
• Capability of travel to Insight Hospital and Medical Center Chicago for study visits, sponsor meetings, and operational needs Feasibility, Regulatory, Contracts, Budgets, and Quality (50%):
• Collaborate with Feasibility and start up/regulatory teams to ensure timely FQ submissions, IRB submissions, amendments, and reporting
• Support contract and budget negotiations, including feasibility review and cost analysis
• Ensure quality standards across documentation, data entry, and essential files
• Participate in internal audits, monitoring visits, and CAPA development
• Maintain alignment with SOPs, GCP, IRB and institutional requirements
• Review study protocols and develop source
• Maintain ISF documentation Cross-Functional Collaboration:
• Serve as a liaison between research operations, regulatory, finance, legal, and executive leadership
• Support strategic planning for site growth, service expansion, and operational scaling
• Contribute to SOP development, process optimization, and system implementation

• Ph.d degree in life sciences, healthcare, or related field (required)
• 5–7 years of clinical research experience, including operational leadership
• Strong knowledge of GCP, FDA regulations, IRB processes, and site management
• Experience with budgets, contracts, and regulatory and quality workflows
• Excellent communication, leadership, and problem-solving skills