Billing Compliance and QC Specialist

2 weeks ago

San Antonio, United States START Center for Cancer Research Full time
Job DescriptionJob DescriptionThe START Center for Cancer Research (“START”) is the world’s largest global phase I oncology clinical trial research site network. Over its 17-year history, START has provided hope to cancer patients in community practices and hospitals by offering access to cutting edge early phase oncology trials throughout the US and Europe. Today, with over 1,300 studies completed, and with research facilities in the United States and in Spain, Portugal, and Ireland, START’s mission is to accelerate the development of new anticancer drugs that will improve the quality of life and survival for patients with cancer and lead to its eventual cure. To date, over 43 therapies tested at START facilities have obtained FDA/EMA approval. Incredibly, while Academic Medical Centers (AMCs) conduct 80% of cancer trials, such trials reach only 20% of the patient population – leaving the majority of patients who are treated in community practices and hospitals without access to a clinical trial when their care journey calls for one. START serves the many – by bringing cancer trials to physicians and their patients in community hospitals and practices when hope is needed most.

START is needed more now than ever before. There are nearly 20 million new cases of cancer per year across the globe, and 50% of all new clinical trials occur in cancer. Yet, AMCs are saturated with too many trials, too few patients, and not enough capacity to meet the demand. As a result, many of the trials in AMC settings take too long and do not reach patients in need. START offers hope to patients, while allowing clinical researchers to conduct essential trials and biopharma companies the ability to run trials on medicines. START’s legacy is rooted in scientific innovation. As an example, in San Antonio, where START was founded in 2007, START treated the first patient ever with Keytruda – the most effective cancer drug in medical history.

We are hiring a Billing Compliance and QC Specialist. This is a remote role.

The Billing Compliance and QC Specialist will perform comprehensive and independent final compliance review (Summary Review) of all documents related to research study billing, including the research study budget, coverage analysis, protocol, contractual terms, informed consent, and other supporting documentation.

Essential Responsibilities:
  • Manage and maintain a program to provide oversight, education, and ongoing support to all areas of START involved in clinical research budgeting and billing to facilitate compliance with all relevant laws, regulations, and policies.
  • Maintain understanding of CMS and FDA regulations relevant to Medicare coverage analysis, as well as other regulations pertaining to conducting a clinical trial, including Federal Anti-Kickback laws, HIPAA, and other relevant regulations.
  • Review and finalize study Billing Grids, ensuring proper documentation of Coverage Analysis decisions.
  • Perform comprehensive and independent final compliance review to ensure harmonization of all documents related to clinical research studies, including the research study budget, protocol, contractual terms, informed consent, and other supporting documentation.
  • Perform review of study budget and calendar entry in Oncore, ensuring alignment with the Coverage Analysis.
  • Perform research billing reviews/audits to ensure compliance with all applicable federal, state and local regulations, laws and rules and institutional billing policies/procedures. Recommend corrective action that will address any identified deficiencies.
  • Collaborate with internal stakeholders to identify training needs. Develop and maintain training plans/programs directed toward clinical research staff that will provide the training needed to ensure appropriate billing for clinical research charges.
  • Assist with the development of metrics for continual assessment and transparency.
  • Collaborate closely with budget and billing team, study team members, and other internal stakeholders to identify opportunities for improvements in clinical research billing practices.
  • Assist with the development of policies and procedures, monitor key performance indicators, and manage routine and special projects related to clinical research budget and billing
  • Assist with data QC to ensure accuracy and alignment across multiple systems (OnCore, Veeva, ARIA, etc.).
Qualifications
  • Bachelor’s degree
  • Medicare Coverage Analysis trained, preferably certified
  • At least 2 years of relevant experience
  • Excellent communication skills, analytical, accuracy and attention to detail
  • Consistently ensure that information is kept private and confidential, releasing information only to appropriate individuals


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