Regulatory Research Coordinator

Lehigh Valley Health Network • Bethlehem, PA

1d • Onsite

About The Position

Imagine a career at one of the nation's most advanced health networks. Be part of an exceptional health care experience. Join the inspired, passionate team at Lehigh Valley Health Network, a nationally recognized, forward-thinking organization offering plenty of opportunity to do great work. LVHN has been ranked among the "Best Hospitals" by U.S. News & World Report for 23 consecutive years. We're a Magnet(tm) Hospital, having been honored five times with the American Nurses Credentialing Center's prestigious distinction for nursing excellence and quality patient outcomes in our Lehigh Valley region. Finally, Lehigh Valley Hospital - Cedar Crest, Lehigh Valley Hospital - Muhlenberg, Lehigh Valley Hospital- Hazleton, and Lehigh Valley Hospital - Pocono each received an 'A' grade on the Hospital Safety Grade from The Leapfrog Group in 2020, the highest grade in patient safety. These recognitions highlight LVHN's commitment to teamwork, compassion, and technology with an unrelenting focus on delivering the best health care possible every day. Whether you're considering your next career move or your first, you should consider Lehigh Valley Health Network. The Regulatory Research Coordinator coordinates activities related to start up, maintenance, and closure of clinical trials within NORI. This role participates in the research process by collaborating with the research staff and physician investigators to ensure regulatory compliance related to the administrative aspects of clinical trials. The coordinator also corresponds with Industry Sponsors, IRB, and NORI administration ensuring regulatory compliance with essential research documents. Lehigh Valley Health Network (LVHN) is the region’s largest employer and health care provider of choice. Our nearly 20,000 health care professionals take pride in what they do and are driven by our mission to heal, comfort and care for the people of our community. LVHN is honored to be certified as a Great Place to Work®. LVHN’s culture of trust – and the positive things colleagues said about working at LVHN when surveyed by Great Place to Work and Fortune – align perfectly with what makes a great workplace. This designation tells you that LVHN is a great place to work from hire to retire. If you are someone who aligns with LVHN’s core values – Compassion, Integrity, Collaboration and Excellence – you will have a rewarding and successful career here.

Requirements

• High School Diploma/GED
• 4 years of experience in secretarial and/or office management.
• General typing abilities.
• Proficient in Microsoft Word.
• Experience with office equipment such as personal computers, fax machine, copiers, printers, and scanners.

Nice To Haves

• 1 year of experience managing the regulatory aspects of a clinical trial or 1 year knowledge of medical terminology.
• Knowledge of medical terminology.
• Proficient in other business software applications.

Responsibilities

• Maintains complete and accurate files of all regulatory documents on each study assigned as per federal regulations.
• Creates and submits documents for review to the IRB for initial opening of a clinical trial, ongoing updates, and annual review submissions.
• Edits and finalizes informed consent documents collaborating with the NORI/IRB office and sponsor of the trial ensuring compliance with local, state, and federal guidelines.
• Disseminates training material to the study teams for each clinical trial to remain in compliance with research policies and tracks the completion of training by each study team member.
• Provides sponsor representatives with regulatory-related information and support during pre-study visits, interim on-site/remote monitoring visits, and closeout visits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED