Associate Director, Radiology IND/IDE Support

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🔥 0 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $80.9k / year

⏰ Full Time

🟠 Senior

👔 Director

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Penn Information Systems & Computing

WebsiteLinkedInAll Job Openings

201 - 500 employees

🔌 API

🤝 B2B

🏢 Enterprise

API • B2B • Enterprise

Penn Information Systems & Computing is the central IT organization at the University of Pennsylvania, recognized as a trusted IT partner. They provide crucial IT services that support and enhance the university's mission, including infrastructure and services for networking, data management, voice and video communication, and enterprise applications. By collaborating with various schools and centers within the university, ISC helps build unique tools and capabilities tailored to the needs of the Penn community.

📋 Description

• Lead the daily operations of the Radiology IND/IDE Support Office • Support and oversee active and pending domestic and international INDs and IDEs • Oversee research operations involving investigational drugs and medical devices sponsored by the Department of Radiology • Liaise with the FDA to ensure compliance with regulations, GCP, institutional policies, SOPs, and SOP requirements • Maintain appropriate Trial Master Files • Develop and implement risk-based study monitoring plans • Review protocols and case report forms • Execute study-specific monitoring visits and complete monitoring reports under OCR Compliance direction • Manage fewer than 10 staff supporting departmental investigators • Supervise and mentor regulatory staff, delegate responsibilities, and ensure timely deliverables • Provide strategic oversight of FDA regulatory, safety reporting, and compliance activities • Maintain inspection-ready documentation and prepare research teams for inspections and audits • Lead cross-functional collaboration among investigators and clinical research professionals • Build partnerships across clinical, regulatory, and operational teams to streamline research and mitigate risk

🎯 Requirements

• Bachelor's degree in a scientific or related discipline (B.S. or B.A.) and 7–10 years of experience as a monitor, or an equivalent combination of education and experience • 5–6 years of relevant experience and a Master's degree preferred • Experience supporting FDA-regulated clinical research, including IND and/or IDE studies • Demonstrated knowledge of FDA regulations, guidance, and compliance requirements applicable to clinical research • Knowledge of risk-based monitoring, regulatory affairs, clinical research operations, research compliance, quality assurance, FDA regulations, GCP, data quality, and strategic operations management • Position is contingent upon grant funding • Background checks may be required after a conditional job offer

🏖️ Benefits

• Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits • Flexible spending accounts for eligible health care and dependent care expenses • Tuition assistance for employees, spouses, and dependent children • Tuition assistance for dependent children at other institutions • Basic, matching, and supplemental retirement plans • Pre-tax or Roth retirement savings options • Investment options through TIAA and Vanguard • Substantial time away from work • Long-term care insurance • Wellness and work-life programs and resources • Professional and personal development resources • Access to University libraries, athletic facilities, arboretum, art galleries, cultural and recreational activities • Discounts and special services for arts, entertainment, transportation, mortgages, cars, cellular service, movie tickets, and theme parks • Flexible work options and flexible work hours • Forgivable loan through Penn Home Ownership Services for eligible employees • Adoption assistance for qualified expenses, up to two adoptions in the household