Associate Director, Radiology IND/IDE Support Office

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🔥 0 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $80.9k / year

⏰ Full Time

🟠 Senior

👔 Director

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University of Pennsylvania Perelman School of Medicine

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

📚 Education

🏥 Healthcare

🤝 Non-profit

Education • Healthcare • Non-profit

University of Pennsylvania Perelman School of Medicine is a distinguished institution dedicated to medical education, research, and patient care. It is part of the University of Pennsylvania and is recognized for its commitment to advancing medical knowledge and training future healthcare professionals.

📋 Description

• Lead the daily operations of the Radiology IND/IDE Support Office • Support and oversee active and pending departmental INDs and IDEs • Oversee sponsor-investigator research involving investigational drugs and medical devices • Liaise with the FDA to ensure compliance with regulations, GCP, institutional policies, SOPs, and Trial Master File requirements • Develop and implement risk-based study monitoring plans • Review protocols and case report forms to protect human subjects and ensure data quality and regulatory compliance • Execute study-specific monitoring visits and complete monitoring reports under OCR Compliance direction • Manage fewer than 10 staff supporting Department of Radiology 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 collaborative 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 required • 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 clinical research compliance requirements • Knowledge of Good Clinical Practice (GCP) • Knowledge of risk-based monitoring, regulatory affairs, clinical research operations, research compliance, quality assurance, FDA regulations, data quality, and strategic operations management • Staff leadership and training experience • Background checks may be required after a conditional job offer • Position is contingent upon grant funding

🏖️ Benefits

• Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits • Flexible spending accounts for eligible health care and dependent care expenses with pre-tax dollars • Tuition assistance for employees, spouses, and dependent children at Penn and eligible tuition assistance at other institutions • Basic, matching, and supplemental retirement plans with pre-tax or Roth 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, including arts and entertainment, transportation, mortgages, cars, cellular phone plans, movie tickets, and theme parks • Flexible work options and flexible work hours • Forgivable home loan for eligible employees buying or residing in West Philadelphia • Adoption assistance for qualified expenses, for up to two adoptions in the household