Research Finance and Compliance Specialist

St. Luke's University Health Network•Allentown, PA

About The Position

St. Luke's is proud of the skills, experience and compassion of its employees. The employees of St. Luke's are our most valuable asset! Individually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care. The Research Finance and Compliance Specialist is responsible for the overall day to day pre- and post-award financial operations of SLUHN industry or grant funded clinical trials. Assists SLUHN and affiliated providers with Billing Coverage Analysis (BCA) development and identifying billable versus non-billable tests/procedures in accordance with The Centers for Medicare & Medicaid Services National Coverage Determination (NCD), local standard of care, and National Comprehensive Cancer Network (NCCN) guidelines.

Requirements

Bachelor’s degree required with a minimum of 2-3 years directly related experience.
In-depth knowledge of Microsoft Office Programs (Word, Excel, PowerPoint, Outlook; Internet Functions) required.
Experience with NIH policies and sponsored research regulations including The Centers for Medicare & Medicaid Services national coverage determination (NCD), and A-133, A-21 and A-110 highly preferred.
Organized and detail oriented, with clear demonstration of leadership skills also highly preferred.

Nice To Haves

Master’s degree with 1-2 years directly related experience preferred.
Clinical research certification (e.g. SoCRA, ACRP, CHRC, etc.) or RN highly preferred.
Directly related experience includes experience in an academic or community medical setting with industry and government grants administration, research-related clinical experience, and/or medical coding experience.
Experience with NIH policies and sponsored research regulations including The Centers for Medicare & Medicaid Services national coverage determination (NCD), and A-133, A-21 and A-110 highly preferred.
Organized and detail oriented, with clear demonstration of leadership skills also highly preferred.

Responsibilities

This position is responsible for pre- and post-award research finance and compliance activities for all funded clinical trial and research contracts undertaken by SLUHN.
Assist Manager in the assessment of all relevant clinical trial documents, including the protocol and Informed Consent Form (ICF), and collaborate with clinical research personnel as well as other ancillary departments in the preparation of Billing Coverage Analyses (BCA) to ensure costs are compliant with local standard of care, routine care, and Medicare billing guidelines.
Independently prepare initial budget spreadsheets, budget proposals, and other supporting documents, as well as any amendments for review with the Manager in support of clinical trial budget and contract negotiation with sponsors, and act as a liaison between site and sponsor through the execution of Clinical Trial Agreements (CTA).
Prepare clinical trial cost analyses for National Clinical Trials Network (NCTN) group studies, observational studies, and other unfunded studies to determine profit or loss.
Identify appropriate Current Procedural Terminology (CPT) and Healthcare Common Procedure Codes (HCPCs) along with the appropriate research rate(s) for procedures outlined in each protocol study schedule.
Set up new clinical trials accounts, and work as a liaison to clinical trials management, SLUHN Finance, and SLUHN Accounting.
Assist in the build of financials and billing Protocols of each study into the department’s Clinical Trials Management System (CTMS) and EPIC EHR system.
Perform daily review and monthly cycle billing compliance reviews on both hospital, professional, and research charges against the final BCA and CTA to ensure compliance with billing guidelines, regulations and contractual terms.
Assist the Manager in the development of standards and templates to ensure consistency in budgeting and billing across all clinical studies.
Reconcile funds and conduct routine and end of study audits as well as resolve identified discrepancies and retain all necessary documentation for department files.