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POSITION SPECIFICS
The Penn State College of Medicine Clinical Trials Office (COM CTO), in Hershey, PA, is dedicated to assisting in advancing clinical research through a commitment to excellence in support, compliance, and collaboration. We strive to ensure billing compliance, develop accurate and fair budgets, and provide robust support for the institution’s Clinical Research Management System (CRMS). Through its oversight of clinical research, the COM CTO ensures that clinical research studies are conducted with integrity, efficiency, and to the highest standards, ultimately contributing to innovative healthcare solutions and improved patient outcomes. By fostering strong partnerships with sponsors and CROs, the COM CTO creates new opportunities that enhance Penn State College of Medicine’s ability to have early access to research clinical studies for cutting-edge, novel therapies. Through educational events, workshops, and workforce development initiatives, the COM CTO empowers our study teams to excel in their research endeavors.
The primary purpose of this position is to conduct payer coverage analyses by reviewing and evaluating oncology and non-oncology clinical research protocols and related regulatory documents to prepare a billing plan for all billable items and services required in a clinical research project. This position is responsible for conducting the coverage analysis for all applicable oncology and non-oncology clinical research studies. In accordance with Medicare’s Clinical Trial Policy (NCD 310.1), the Payer Coverage Analyst will complete an analysis to ensure billing determinations comply with national and local guidelines and in compliance with all other applicable statutory requirements. As necessary throughout the life cycle of the study, the Payer Coverage Analyst will engage with the study team, post award team, patient financial services, Research Quality Assurance, the IRB and other departments as necessary to ensure and facilitate billing compliance.
Primary duties include:
- Payer Coverage Analysis
- Reviews trial related documents (i.e., protocol, consent, grant/trial agreement, budget, Investigator’s Brochure, etc.) for new and amended research protocols submitted to the Clinical Trials Office.
- Identifies billable items and services based on trial related documents provided
- Interprets and applies knowledge of billing guidelines as identified in national and local coverage determinations, compendia, and literature support as needed to make billing determinations of items and services within a research protocol.
- Meets and discusses coverage analysis determinations with the research team (investigators, research staff, financial analysts) and CTO Clinical Research Budget Analysts any potential concerns identified with the payer coverage analysis.
- Budget Development Support
- Drafts the Coverage Analysis Review and Study Billing Grid(s) to direct payer coverage analysis, identifying billable items and services, and assigning billing determinations
- Attends budget meetings to facilitate discussion with the study team related to billing determinations of items and services within a research protocol.
- Meets with CTO Clinical Research Budget Analysts to review billing determinations in establishing a research protocol budget.
- Clinical Research Management System (CRMS) Study Design and Management:
- Assists with building clinical research studies into the CRMS by converting the study protocol and negotiated budget into a user-friendly interface to ensure billing compliance and proper management of study funds.
- Provides user support throughout the life cycle of each trial, including making updates to studies in the CRMS based on protocol and/or coverage analysis.
- Collaborates with clinical research budget analysts, patient financial services, study teams, and post-award financial analysts to resolve research billing compliance issues.
- Education and Training
- Provides subject matter expertise to College of Medicine colleagues involved in all pre-award and post-award processes.
- Assists in interviewing, training, and mentoring of CTO staff, including teaching best practices for performing payer coverage analysis of oncology and non-oncology clinical research.
- Engages in one-on-one meetings with both faculty and research staff from other departments outside the CTO, as needed, to provide in-depth generalized clinical research training, as well as project-specific guidance.
- Assists in developing faculty and research staff education programs on specialized research administration topics. Disseminates new knowledge and best practices through various platforms including but not limited to CTO workshops and other ad hoc groups.
- Regulatory and Institutional Compliance
- Completes the HRP-903 Radiation Review Form and the Ancillary Review for studies via CATS IRB, as applicable, collaborating with the Radiation Review Committee as necessary.
- Completes the CTO Ancillary Review for studies via CATS IRB, as necessary
This position can be on-site, hybrid, or remote.
Preferred Experience
Well-qualified candidates will have experience in at least one of the following areas:
- ACRP or SoCRA certification
- Clinical research study coordination experience
- Clinical background (e.g., RN, LPN, EMT-P, RT, Pharmacist, etc.) strongly preferred
Intermediate Professional
Performs Medicare Coverage Analysis on non-oncology drug studies. May perform Medicare Coverage Analysis on device studies in close collaboration with a more senior member of the team.
Advanced Professional
Provides Medicare Coverage Analysis on non-oncology studies and cooperative group oncology studies independently. May perform Medicare Coverage Analysis on sponsored oncology studies in close collaboration with a more senior member of the team.
Senior Professional
Provides Medicare Coverage Analysis on oncology and non-oncology studies.
Principal Professional
Provides Medicare Coverage Analysis on oncology and non-oncology studies.
MINIMUM EDUCATION, WORK EXPERIENCE & REQUIRED CERTIFICATIONS
BACKGROUND CHECKS/CLEARANCES
Employment with the University will require successful completion of background check(s) in accordance with University policies.
Penn State does not sponsor or take over sponsorship of a staff employment Visa. Applicants must be authorized to work in the U.S.
SALARY & BENEFITS
The salary range for this position, including all possible grades, is $51,000.00 – $115,100.00.
Penn State provides a competitive benefits package for full-time employees designed to support both personal and professional well-being. In addition to comprehensive medical, dental, and vision coverage, employees enjoy robust retirement plans and substantial paid time off which includes holidays, vacation and sick time. One of the standout benefits is the generous 75% tuition discount, available to employees as well as eligible spouses and children. For more detailed information, please visit our
CAMPUS SECURITY CRIME STATISTICS
Pursuant to the Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act and the Pennsylvania Act of 1988, Penn State publishes a combined Annual Security and Annual Fire Safety Report (ASR). The ASR includes crime statistics and institutional policies concerning campus security, such as those concerning alcohol and drug use, crime prevention, the reporting of crimes, sexual assault, and other matters. The ASR is available for review
EEO IS THE LAW
Penn State is an equal opportunity employer and is committed to providing employment opportunities to all qualified applicants without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If you are unable to use our online application process due to an impairment or disability, please contact 814-865-1473.
The Pennsylvania State University is committed to and accountable for advancing equity, respect, and belonging. We embrace individual uniqueness, as well as a culture of belonging that supports equity initiatives, leverages the educational and institutional benefits of inclusion in society, and provides opportunities for engagement intended to help all members of the community thrive. We value belonging as a core strength and an essential element of the university’s teaching, research, and service mission.
- Payer Coverage Analysis