Associate Director Research Operations

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 Systems 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)
57 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