Clinical Research Regulatory Specialist B (Abramson Cancer Center)

University of Pennsylvania • Philadelphia, PA

431d • $51,824 - $86,000

About The Position

The Clinical Research Regulatory Specialist B at the Abramson Cancer Center is responsible for facilitating the regulatory aspects of initiating Phase I-V clinical trials, focusing on obtaining necessary regulatory approvals and managing site initiation documentation. This role involves preparing and processing regulatory submissions, resolving queries, and providing guidance on investigator-initiated trials, all while working collaboratively with various teams.

Requirements

• Bachelor's degree in a life science or human subject protection field.
• 3-5 years of research experience or equivalent combination of education and experience required.
• At least 2 years of regulatory experience preferred.
• Experience conducting high-risk biomedical research and/or oncology regulatory research preferred.
• Research credentialing (CCRP, CIP, etc.) preferred.
• Effective problem-solving and critical thinking abilities.
• Strong communication and writing skills.
• Excellent organizational and time management skills.
• Ability to work as part of a team and independently.
• Working knowledge of IRB and human research protection regulations, including ICH GCP guidelines.
• Self-driven with heightened attention to detail.
• Intermediate/expert level in Microsoft Office applications and team interconnectivity tools.

Nice To Haves

• Knowledge of web-based e-regulatory document management systems such as eFlorence or Veeva Systems products.

Responsibilities

• Facilitate regulatory aspects of Phase I-V clinical trials initiation with minimal supervision.
• Prepare and process initial oversight submissions for regulatory documentation through IRB, CTSRMC, FDA, and other institutional review committees.
• Collaborate with the Regulatory Affairs Administrative Coordinator to manage regulatory documentation for pharmaceutical companies and CROs.
• Organize and maintain all regulatory affairs documentation and files as required.
• Resolve regulatory queries and participate in the initiation of new studies.
• Communicate the transition of new studies to applicable team members post-site initiation.
• Participate in regulatory staff meetings, research team meetings, and ongoing protocol training/compliance meetings.
• Oversee the development of investigator-initiated research protocols and FDA IND applications.

Benefits

• Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance.
• Tuition assistance for employees and their families.
• Generous retirement plans with various investment options.
• Substantial time away from work for personal needs.
• Long-term care insurance for faculty and staff and eligible family members.
• Wellness and work-life resources to support health and balance.
• Professional and personal development resources.
• Access to University resources and cultural activities.
• Discounts on goods and services for faculty and staff.
• Flexible work hours to promote work-life balance.
• Adoption assistance for qualified expenses related to legal adoption.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Educational Services
• Education Level: Bachelor's degree