Associate Director, Radiology IND/IDE Support

Emploi pas sur LinkedIn

🕒 il y a 1 mois

🔔 Pennsylvania – Distant

🔔 Pennsylvania – Remote

💵 $80 891 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

👻 Score fantôme 4%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Penn Information Systems & Computing

Site WebLinkedInTous les Emplois

201 - 500 employés

🔌 API

🤝 B2B

🏢 Entreprise

API • B2B • Enterprise

ISC est le partenaire informatique de confiance de Penn, collaborant avec la communauté Penn sur des services IT qui améliorent et soutiennent la mission de l'Université.

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

🎯 Exigences

• 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

🏖️ Avantages

• 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