Associate Director Regulatory Affairs

UnitedHealth Group • Minnetonka, MN

250d • $106,800 - $194,200 • Remote

About The Position

UnitedHealth Group is a health care and well-being company that's dedicated to improving the health outcomes of millions around the world. We are comprised of two distinct and complementary businesses, UnitedHealthcare and Optum, working to build a better health system for all. Here, your contributions matter as they will help transform health care for years to come. Make an impact with a diverse team that shares your passion for helping others. Join us to start Caring. Connecting. Growing together. This new position is an impactful and strategic leadership role for the organization's emerging centralized research ethics and integrity program. As Associate Director of Research Integrity, you will contribute to the development of enterprise wide research integrity policies and procedures. You will play a crucial role in expanding our ability to support research sites and investigators, increasing internal capabilities for research, and implementing effective strategies to ensure a consistently ethical and compliant research environment. You'll enjoy the flexibility to work remotely from anywhere within the U.S. as you apply your creative problem-solving skills to a unique set of challenges.

Requirements

• 5+ years of experience in human research regulatory affairs and application of human subjects research protection regulations
• Experience with compliance aspects of research integrity and oversight
• Detailed knowledge of applicable federal regulations related to IRB and clinical research (Common Rule, Belmont Report, Declaration of Helsinki, FDA, HIPAA, ICH, GCP)
• Understanding of the operational requirements related to the management and implementation of the IRB review process and human research protections programs
• Proven attention to detail and ability to maintain strict standards of confidentiality in dealing with protected information
• Demonstrated excellent oral and written communication, problem solving and analytical skills necessary to quickly identify and synthesize salient features from a fast-paced discussion of highly technical broad-ranging information into a cohesive and well-written correspondence to researchers and other audiences
• Demonstrated ability to collect, analyze and incorporate additional technical information from a variety of sources into this process

Nice To Haves

• Leadership experience

Responsibilities

• Support the VP and Director of Human Research Affairs to establish and maintain a centralized Research Ethics and Integrity review program
• Contribute to the design, socialization and roll out of a comprehensive electronic submission system for research oversight
• Engage with leadership from UnitedHealth Care, Optum, and other affiliates to understand researcher needs and pain points to offer research ethics and integrity solutions that align with local objectives and resources
• Collaborate with Legal, Compliance and Regulatory Affairs teams across the enterprise to develop research policies, procedures, and best practices
• Assist with screening incoming IRB submissions for completeness and compliance
• Provide consultation to individual study teams developing research proposals and protocols to ensure design integrity and ethical treatment of human participants
• Maintain a robust research pipeline and track research activities
• Stay updated with regulatory and research trends related to emerging technologies
• Continuously enhance knowledge and skills through professional development opportunities, industry certifications, and networking activities

Benefits

• Comprehensive benefits package
• Incentive and recognition programs
• Equity stock purchase
• 401k contribution

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Industry: Insurance Carriers and Related Activities