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Associate Director Clinical Operations Biotech Jobs in Michigan

Insight

Associate Director Research Operations

Flint, MI · On-site

$140 - $190/hr

Flint, MI Job Id: 2496 # of Openings: 1 Insight Health System Clinical Research Associate Director, Research Operations Title: Associate Director - Research Operations Location: Michigan Reports To:

AMC Health

VP, Clinical Operations

Lansing, MI · On-site

The VP will partner closely with Medical Directors, Product, Technology, Data Science, and Client Success teams to support program implementation, clinical workflow optimization, and operational ...

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Associate Director Research Operations

Insight

Flint, MI • On-site

$140 - $190/hr

Other

Re-posted 12 hours ago

Job description

Position:Associate Director Research Operations

Location: Flint, MI

Job Id:2496

# of Openings:1

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
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