Insight Health System Clinical Research
JOB DESCRIPTION
Associate Director, Research Operations
Title: Associate Director - Research Operations
Location: Michigan
Reports To: Director of Research Operations
Schedule: Full-time, with flexibility for study visits, sponsor meetings, and operational needs
Position Summary:
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.
Key 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
• Capability of 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
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
