Associate Director Research Operations

Iinn; Chicago, Northern (IL, KY); Hybrid; USD 150,000 - 190,000; Full time

Job summary

Insight Hospital and Medical Center Chicago is seeking an Associate Director of Research Operations to lead clinical trials operations and oversee feasibility, regulatory, contracts, budgets, and quality functions across the network.

The role combines operational leadership with regulatory and financial oversight, ensuring compliant, efficient execution of research activities. Travel for study visits and sponsor meetings is required as needed.

Qualifications

• PhD in life sciences, healthcare, or related field.
• 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.

Responsibilities

• Oversee clinical research operations and ensure protocol adherence.
• Support site managers and staff to ensure visits are executed and enrollment monitored.
• Coordinate with cross-functional teams to optimize workflow and resource allocation.
• Ensure regulatory, budget, and quality documentation across studies.
• Maintain SOPs, GCP, IRB compliance, and CAPA processes.

Education

PhD in life sciences

Job description

Insight Hospital and Medical Center Chicago

Research Department

JOB DESCRIPTION

Associate Director, Research Operations

Title: Associate Director – Research Operations
Location: Chicago
Reports To: Director of Research Operations
Schedule: Full-time remote (Home), with flexibility for study visits, sponsor meetings, and operational needs

Position Summary

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 Responsibilities

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

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

Minimum Qualifications

• 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