Clinical Research Coverage Analyst

Saint Louis University•St. Louis, MO

2d•$58,000 - $72,000•Hybrid

About The Position

Under general direction, provides education and training to the clinical research community of the School of Medicine regarding clinical research studies; contributes to compliant research billing practices by making determinations of qualifying clinical trial (QTC) status and performing detailed coverage analysis (CA). Promotes and supports accurate billing practices to be compliant with Medicare and third-party payment rules. Assists in streamlining research study activation and ensures compliance with federal/state and local regulations as well as University guidelines. This role is available for hybrid or remote work in the following states: Alabama, Arizona, California, Colorado, Illinois, Indiana, Kansas, Maine, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, North Carolina, Ohio, Oklahoma, Rhode Island, Tennessee, Texas, Utah, Virginia, West Virginia, and Wisconsin.

Requirements

Knowledge of regulations and guidelines related to clinical research
Working knowledge of clinical research and multiple medical conditions
Working knowledge of Medicare/Medical billing processes
Organizational, analytical, and decision-making skills
Excellent verbal and written communication skills
Ability to read and comprehend complex materials
Detail oriented with ability to independently research source materials and develop reasonable approaches to issues as they arise
Ability to speak to groups, conduct educational sessions, and adapt teaching styles to learners
Ability to operate computer and various software
Ability to maintain confidentiality
Bachelor’s degree, supplemented with three (3) years of related experience, preferably in the field of clinical research; or Associate’s degree, supplemented with five (5) years of related experience, preferably in the field of clinical research. If the candidate does not have a degree, seven (7) years of related experience is required, preferably in the field of clinical research.

Nice To Haves

1-2 years’ direct experience completing Medicare Coverage Analysis
Experience with research activity in an academic medical center
CPT coding experience

Responsibilities

Reviews clinical trial protocols to determine if each new study is a qualified clinical trial pursuant to CMS policy; creates a detailed Coverage Analysis using clinical trial documents to designate which procedures/services may be “routine care” and billable to patient insurance and which should be billed to the study sponsor based on relevant regulations and determinations.
Serves as National and Local Coverage Determination (NCD and LCD) subject matter expert.
Interfaces with study teams and sponsors to resolve discrepancies in specific protocol assessments.
Interfaces with study teams and principal investigators to assist with coverage analysis determinations.
Performs document review for alignment for each study.
Acts as liaison with partnering hospital to ensure each new study is built in the electronic medical record (EMR) system: submits build forms, maintains spreadsheet of builds, requests updates / corrections as needed.
Provides education for clinical research within the University community; conducts training sessions and develops tools and standardized policies related to the conduct of clinical research; develops a training program for the University clinical research coordinators to conduct clinical research.
Assists with the management of clinical trials organization; attends meetings; performs other duties as assigned.