Virtua Health - Job Description

Position Overview

Virtua Health is dedicated to serving the community by providing exceptional care across various health needs, from wellness and prevention to specialized treatments. As a Magnet-recognized health system, Virtua Health is ranked by U.S. News and World Report and has received multiple awards for quality, safety, and its work environment. With over 14,000 colleagues, including more than 2,850 physicians, physician assistants, and nurse practitioners, Virtua Health offers advanced technologies and treatments across its hospitals, emergency departments, urgent care centers, and numerous other locations. Affiliations with Penn Medicine and the Children's Hospital of Philadelphia further enhance its capabilities.

Employment Details

• Employment Type: Full-time Employee (Regular)
• Time Type: Full-time
• Work Shift: Standard
• Total Weekly Hours: 40
• Location: 100% Remote
• Eligible Remote Locations: AZ, CT, DE, FL, GA, ID, KY, MD, MO, NC, NH, NJ, NY, PA, SC, TN, TX, VA, WI, WV
• Additional Information: Occasional on-site work may be required. Commutable distance to Marlton, NJ is preferred.

Job Summary

The role involves coordinating regulatory activities for Phase II-IV clinical trials. This includes preparing and processing all regulatory documentation for the Clinical Research Program, managing IRB documents and protocols for various IRBs (local, central, external) and review committees. Responsibilities encompass new submissions, continuing reviews, amendments, adverse events, and reportable events. The position also involves organizing and maintaining regulatory documents for assigned protocols and participating in quality audits.

Position Responsibilities

• Regulatory Document Preparation and Submission:
  • Prepare and submit regulatory documents and correspondence to Institutional Review Boards (IRBs).
  • Prepare new and renewal applications, amendments, continuing reviews, reportable events, consent forms, revised consent forms, protocol deviations, and adverse event reporting.
  • Ensure timely and accurate completion and filing of all required reports and regulatory documents in compliance with regulatory agencies and local, external, and central IRBs and research review committees.
  • Keep Principal Investigators, sub-investigators, and study teams informed about regulatory operations and the activation process.
• Regulatory Document Management:
  • Manage and organize regulatory study documentation and study files in accordance with sponsor, regulatory requirements, and internal policies.
  • Maintain essential documents including study protocols, consents, amendments, financial disclosure forms, FDA 1572 forms, study site logs, and others.
• Operational Support and Compliance:
  • Develop regulatory standard operating procedures (SOPs) aligned with clinical research best practices.
  • Prepare and organize all regulatory documents for audits and monitoring visits.
  • Participate in quality audits.
  • Conduct administrative and regulatory activities to support clinical trial conduct and the daily operations of the clinical research program.
  • Assist with study implementation, study close-out, follow-up, and facilitate communication between study sites, principal investigators, and sub-investigators.

Company Information

At Virtua Health, our mission is to serve you better by being present in all the moments that matter. We strive to connect you with the care you need, whether it's for wellness, prevention, specialized treatments, or life-changing care. We are your partner in health, dedicated to building a healthier community. Our exceptional medical and surgical experts are recognized nationally, and we are committed to providing outstanding care close to home. Virtua Health is a Magnet-recognized health system, consistently ranked by U.S. News and World Report and awarded for quality, safety, and our work environment. We are also affiliated with Penn Medicine for cancer and neurosciences, and the Children's Hospital of Philadelphia for pediatrics.