Pre Award Specialist

Lehigh Valley Health Network • Allentown, 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. This position provides direct support to Lehigh Valley Health Network (LVHN) Principal Investigators, Network Office of Research and Innovation (NORI) leadership, and study team members in the preparation and facilitation of clinical study feasibility reviews, Medicare Coverage Analysis (MCA) development, and budget and contract preparation and negotiation. It also facilitates the pre-award process for grant funded studies as needed and ensures compliance with federal and state laws, regulations, and governmental or sponsor requirements, as well as NORI and LVHN Standard Operating Procedures.

Requirements

• Bachelor’s Degree in Nursing, Accounting, or Finance
• 2 years of experience analyzing, drafting, and negotiating complex budgets and agreements or 2 years of experience working in clinical research
• In depth knowledge of Microsoft Office Programs: Word, Excel, PowerPoint, and Outlook.

Nice To Haves

• 2 years of experience working in a clinical trials office or 2 years of experience working in a healthcare environment.
• Knowledge of the Centers for Medicare and Medicaid Services (CMS) national coverage determinations (NCDs).
• Knowledge of FDA Good Clinical Practices, OMB Circular A-110, A-122, and A-133, OHRP, and AAHRPP guidance, 21 CFR Parts 11, 50, 54, 56, 312 and 812, 45 CFR Part 46, and other applicable research regulations.

Responsibilities

• Facilitates study feasibility process including review of study financial and operational feasibility.
• Leads study feasibility meetings with study team, Principal Investigator, and NORI leadership.
• Prepares study Medicare Coverage Analysis (MCA) to ensure research related charges are billed appropriately per applicable guidelines and regulations.
• Develops and effectively negotiates budgets and contracts, ensuring that all potentially associated personnel and procedure costs are covered.
• Builds and maintains overall study record in department's Clinical Trials Management System (CTMS).
• Reviews and processes study protocol amendments.
• Facilitates pre-award process for grant funded research projects as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level