Pre Award Specialist

Career At Lehigh Valley Health Network

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.

Job Title

Clinical Study Feasibility Coordinator

Job Description

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. Facilitates pre-award process for grant funded studies as needed. Ensures compliance with federal and state laws, regulations, governmental or sponsor requirements, as well as NORI and LVHN Standard Operating Procedures.

Job Duties

• 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.

Minimum Qualifications

• 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.

Preferred Qualifications

• 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.

Additional Qualifications Physical Demands Lift and carry 25 lbs. frequent sitting/standing, frequent keyboard use, *patient care providers may be required to perform activities specific to their role including kneeling, bending, squatting and performing CPR.

Job Description Disclaimer: This position description provides the major duties/responsibilities, requirements and working conditions for the position. It is intended to be an accurate reflection of the current position, however management reserves the right to revise or change as necessary to meet organizational needs. Other responsibilities may be assigned when circumstances require.

Lehigh Valley Health Network is an equal opportunity employer. In accordance with, and where applicable, in addition to federal, state and local employment regulations, Lehigh Valley Health Network will provide employment opportunities to all persons without regard to race, color, religion, sex, age, national origin, sexual orientation, gender identity, disability or other such protected classes as may be defined by law. All personnel actions and programs will adhere to this policy. Personnel actions and programs include, but are not limited to recruitment, selection, hiring, transfers, promotions, terminations, compensation, benefits, educational programs and/or social activities.