Associate Director for Clinical Trials Billing Compliance
Department:
Clinical Research Compliance-621200 Career Area :
Research Professionals Posting Open Date:
07/24/2023 Application Deadline:
08/31/2023 Open Until Filled:
No Position Type:
Permanent Staff (EHRA NF) Working Title:
Associate Director for Clinical Trials Billing Compliance Appointment Type:
EHRA Non-Faculty Position Number:
20001743 Vacancy ID:
NF0007213 Full Time/Part Time:
Full-Time Permanent FTE:
1 Hours per week:
40 Position Location:
North Carolina, US Hiring Range:
Dependent on Experience/Qualifications Proposed Start Date:
09/04/2023 Primary Purpose of Organizational Unit:
The core purpose of the Office of Clinical Trials (OCT) to ensure compliance with federal, state and institutional requirements by performing the following functions:
- Supporting the Human Research Protection Program by conducting post IRB approval of clinical studies through the Clinical Trials Quality Assurance (CTQA) program - Ensuring correct clinical trial billing of research subjects through the Research Billing Compliance Program - Ensuring compliance with the ClinicalTrials.
gov registration results reporting - Ensuring compliance by reviewing the billing coverage analysis, fully executed agreement, and IRB approved consent form for congruency and accuracy - Coordinating the Scientific Review Committee and serving as a resource for protocol development for the research community - Serving as the point of contact for questions or issues related to clinical trials - Developing and implementing programs and initiatives to enhance the quality of clinical research and support regulatory compliance, through the implementation of the OnCore clinical trials management system enterprise wide - Providing education, consultation and guidance on the conduct of clinical trials as requested Position
Summary:
This position may be eligible for a hybrid work arrangement that may include a partially remote work location, consistent with System Office policy.
UNC Chapel Hill employees are generally required to reside within a reasonable commuting distance of their assigned duty station.
UNC's Office of Clinical Trials Research Billing Compliance program is dedicated to ensuring billing compliance for clinical research.
A coverage analysis harmonizes the clinical trials protocol, budget, contract, and informed consent to determine what is billable to insurance based on federal/state billing regulations including Medicare's National Coverage Decision (NCD) 310.
1 as well as other third-party billing rules.
It ensures consistent application of Medicare rules across studies, as well as consistent application of study documents.
The Associate Director for Clinical Trials Billing Compliance will report the to the Director of the Office of Clinical Trials and will have the following
Responsibilities:
Maintaining a program to provide oversight, education, and ongoing support to all areas of UNC involved in clinical research billing to facilitate compliance with all relevant laws, regulations, and policies.
Overseeing a staff responsible for the development of BCA (mixed billing designation, QCT, justifications for billing insurance, clear and concise guidance to clinical teams, and coding of procedures) for clinical trials, ranging from device to oncology trials.
Being well-versed in 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.
Training staff, assisting with the development of policies and procedures, continuous monitoring of key performance indicators, supervising routine and special projects analysis, and assuring the accuracy and completeness of coverage analyses.
Working closely with UNC Health Revenue Cycle Research Billing Review and the OnCore CTMS teams.
Assisting with the development of accurate billing coverage analysis such that the University can bill appropriately, effectively, and compliantly for clinical research tests and procedures.
Promoting consistency in payment terms as related to the research study contract, budget protocol, informed consent, Billing Coverage Analysis (BCA), and separation of allowable costs.
Developing and implementing workflows within and between OnCore and Epic.
Assisting with the development of metrics for continual assessment and transparency to achieve successful startup times, billing issuance timelines, and compliant and timely billing issuance.
Partner with UNC Health Revenue Cycle Team, Research Billing Review team on communication for studies.
Ensuring claim audits are performed for variance and analysis for claims is performed on appropriate standards.
Maintaining an ongoing prioritized requirements list and utilizing it for continuous improvement.
Working with internal stakeholders, resources, and vendors to coordinate related education and training associated with adoption of improved processes or systems and education of the importance of standard business practices.
Minimum Education and Experience Requirements:
Relevant post-Baccalaureate degree required (or foreign degree equivalent); for candidates demonstrating comparable independent research productivity or professional-level background in sponsored research administration, will accept a relevant Bachelor's degree (or foreign degree equivalent) and 3 or more years of relevant experience in substitution.
Required Qualifications, Competencies, and
Experience:
The successful candidate will demonstrate an understanding of clinical trial billing including Medicare coverage analysis, National Coverage Decision 310.
1, and medical billing coding related to clinical trials.
The individual filling this position must have substantial experience with clinical research administration.
Preferred Qualifications, Competencies, and
Experience:
It is strongly preferred that the individual in this position have at least five to seven years in a university or healthcare setting.
All BCAs are developed within the clinical trial management system so experience using OnCore or similar systems is a plus.
Master's degree or higher preferred.
Campus Security Authority
Responsibilities:
This position is designated as a Campus Security Authority in accordance with the Clery Act.
This position will be required to report Clery crimes to the Clery Compliance Manager and complete annual training about reporting responsibilities.
Recommended Skills Pre Clinical Development Clinical Study Design Medical Writing Drug Development Clinical Trials Electronic Common Technical Document Estimated Salary: $20 to $28 per hour based on qualifications.
Clinical Research Compliance-621200 Career Area :
Research Professionals Posting Open Date:
07/24/2023 Application Deadline:
08/31/2023 Open Until Filled:
No Position Type:
Permanent Staff (EHRA NF) Working Title:
Associate Director for Clinical Trials Billing Compliance Appointment Type:
EHRA Non-Faculty Position Number:
20001743 Vacancy ID:
NF0007213 Full Time/Part Time:
Full-Time Permanent FTE:
1 Hours per week:
40 Position Location:
North Carolina, US Hiring Range:
Dependent on Experience/Qualifications Proposed Start Date:
09/04/2023 Primary Purpose of Organizational Unit:
The core purpose of the Office of Clinical Trials (OCT) to ensure compliance with federal, state and institutional requirements by performing the following functions:
- Supporting the Human Research Protection Program by conducting post IRB approval of clinical studies through the Clinical Trials Quality Assurance (CTQA) program - Ensuring correct clinical trial billing of research subjects through the Research Billing Compliance Program - Ensuring compliance with the ClinicalTrials.
gov registration results reporting - Ensuring compliance by reviewing the billing coverage analysis, fully executed agreement, and IRB approved consent form for congruency and accuracy - Coordinating the Scientific Review Committee and serving as a resource for protocol development for the research community - Serving as the point of contact for questions or issues related to clinical trials - Developing and implementing programs and initiatives to enhance the quality of clinical research and support regulatory compliance, through the implementation of the OnCore clinical trials management system enterprise wide - Providing education, consultation and guidance on the conduct of clinical trials as requested Position
Summary:
This position may be eligible for a hybrid work arrangement that may include a partially remote work location, consistent with System Office policy.
UNC Chapel Hill employees are generally required to reside within a reasonable commuting distance of their assigned duty station.
UNC's Office of Clinical Trials Research Billing Compliance program is dedicated to ensuring billing compliance for clinical research.
A coverage analysis harmonizes the clinical trials protocol, budget, contract, and informed consent to determine what is billable to insurance based on federal/state billing regulations including Medicare's National Coverage Decision (NCD) 310.
1 as well as other third-party billing rules.
It ensures consistent application of Medicare rules across studies, as well as consistent application of study documents.
The Associate Director for Clinical Trials Billing Compliance will report the to the Director of the Office of Clinical Trials and will have the following
Responsibilities:
Maintaining a program to provide oversight, education, and ongoing support to all areas of UNC involved in clinical research billing to facilitate compliance with all relevant laws, regulations, and policies.
Overseeing a staff responsible for the development of BCA (mixed billing designation, QCT, justifications for billing insurance, clear and concise guidance to clinical teams, and coding of procedures) for clinical trials, ranging from device to oncology trials.
Being well-versed in 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.
Training staff, assisting with the development of policies and procedures, continuous monitoring of key performance indicators, supervising routine and special projects analysis, and assuring the accuracy and completeness of coverage analyses.
Working closely with UNC Health Revenue Cycle Research Billing Review and the OnCore CTMS teams.
Assisting with the development of accurate billing coverage analysis such that the University can bill appropriately, effectively, and compliantly for clinical research tests and procedures.
Promoting consistency in payment terms as related to the research study contract, budget protocol, informed consent, Billing Coverage Analysis (BCA), and separation of allowable costs.
Developing and implementing workflows within and between OnCore and Epic.
Assisting with the development of metrics for continual assessment and transparency to achieve successful startup times, billing issuance timelines, and compliant and timely billing issuance.
Partner with UNC Health Revenue Cycle Team, Research Billing Review team on communication for studies.
Ensuring claim audits are performed for variance and analysis for claims is performed on appropriate standards.
Maintaining an ongoing prioritized requirements list and utilizing it for continuous improvement.
Working with internal stakeholders, resources, and vendors to coordinate related education and training associated with adoption of improved processes or systems and education of the importance of standard business practices.
Minimum Education and Experience Requirements:
Relevant post-Baccalaureate degree required (or foreign degree equivalent); for candidates demonstrating comparable independent research productivity or professional-level background in sponsored research administration, will accept a relevant Bachelor's degree (or foreign degree equivalent) and 3 or more years of relevant experience in substitution.
Required Qualifications, Competencies, and
Experience:
The successful candidate will demonstrate an understanding of clinical trial billing including Medicare coverage analysis, National Coverage Decision 310.
1, and medical billing coding related to clinical trials.
The individual filling this position must have substantial experience with clinical research administration.
Preferred Qualifications, Competencies, and
Experience:
It is strongly preferred that the individual in this position have at least five to seven years in a university or healthcare setting.
All BCAs are developed within the clinical trial management system so experience using OnCore or similar systems is a plus.
Master's degree or higher preferred.
Campus Security Authority
Responsibilities:
This position is designated as a Campus Security Authority in accordance with the Clery Act.
This position will be required to report Clery crimes to the Clery Compliance Manager and complete annual training about reporting responsibilities.
Recommended Skills Pre Clinical Development Clinical Study Design Medical Writing Drug Development Clinical Trials Electronic Common Technical Document Estimated Salary: $20 to $28 per hour based on qualifications.
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