Note: The job is a remote job and is open to candidates in USA. Insight Health Systems is seeking an Associate Director of Research Operations to support clinical research activities at Insight Hospital and Medical Center Chicago. The role oversees clinical trial operations while managing feasibility, start-up, regulatory, contracts, budgets, and quality functions, ensuring compliance and efficient research execution across the network.
Responsibilities
- 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
- 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
- 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
Skills
- • 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
Benefits
- Full-time remote (Home), with flexibility for study visits, sponsor meetings, and operational needs
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