Associate Director Research Operations

Location: Michigan

Reports To: Director of Research Operations

About the Role

The Associate Director of Research Operations is responsible for supporting Insight Health System’s clinical research enterprise across multiple sites. 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.

Responsibilities

Clinical Operations Leadership (50%)

• Oversee day-to-day clinical research operations across assigned regions/sites
• 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
• Travel between multiple locations as needed to support operational activities

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

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

Schedule

Full-time, with flexibility for study visits, sponsor meetings, and operational needs