Associate Director, Study Start Up & Billing Compliance

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Occupational Summary
Assist the Director of Research Operations and the Associate Dean of Clinical Research with responsibilities associated with Study Initiation, Coverage Analysis and Research Charge Adjudication. Serve as liaison and subject matter expert for clinical research study start up, research billing and charge review. Facilitate collaborations across the Schools of Medicine and Nursing and Duke Health on behalf of DOCR. Lead and implement initiatives and programs to ensure high quality and efficient study start up processes, including calendar-building and coverage analysis. Ensure accurate and timely adjudication of all DUHS and Non DUHS charges under DOCR Central Charge Review. Lead and provide direction to staff who perform study start up, coverage analysis determination and research charge review activities to include: supervision and management of staff, forecasting hiring, development and review of processes, input for budget development, and education and training of staff. Guarantee adherence/compliance with federal regulations/guidelines, state laws and local policies and procedures around clinical research billing. Advise appropriate institutional officials of deficiencies, provide metrics as requested, recommend necessary corrective actions, and monitor with follow up to ensure that needed actions have been implemented.

Work Performed
Essential Duties

Leadership, Strategic Planning, and Management

Act as the subject matter expert and liaison among internal DOCR resources (Maestro Care for Research, OnCore), other Duke entities (DUHS Compliance, ORC, ORAQ, DHTS and PRMO) and researchers across the organization in matters regarding study start up, research billing and charge review operations.

Assist directors with financial oversight, budget management, personnel and staffing, space and facilities, and DOCR initiatives. Provide oversight regarding customer stewardship; expectations management; and development, management, and analysis of satisfaction metrics to provide suggestions for customer service improvements.

Work closely with Clinical Research Unit research and financial practice managers to determine CRU clinical research study start up process needs and develop standardized delivery models. Interface with CRU directors on research process plans to seek guidance and buy-in for initiatives.

Participate in the development of communications to improve understanding of policies and practices for the research community through newsletter, CRU newsletter, DOCR website and portal, and other

School of Medicine Communication Channels. Spearhead project plans and initiatives of DOCR including regulatory compliance, roles and responsibilities, GCP, and other research domains.

Represent Duke in local and national professional associations by serving on committees and presenting at conferences; stay current with regulatory standards and contribute to the knowledge of the profession.

Oversee staff on the Study Initiation and Central Charge Review teams in their assigned internal responsibilities. Perform routine personnel functions, including but not limited to time and attendance monitoring, hiring, performance appraisals, promotions, space management and staff development assessments. Resolve problem situations related to staffing, onboarding, and management of employees. Identify and develop potential career paths and growth opportunities for team members, including identifying opportunities for training, mentoring, shadowing, participation in workshops, and presentation development.

Operations

In collaboration with the OnCore and Maestro Care teams, lead processes to streamline study start up and billing/charge review process and oversight in OnCore and Maestro Care. Ensure compliance with IRB, University, and applicable sponsor and payor regulations.

Provide regular reports to stakeholders [CRUs, Study Teams, School of Medicine Finance, DUHS Compliance and the Office of Audit, Review and Compliance (OARC)] regarding trends and outliers in study initiation and charge review processes.

Meet regularly with individuals from PRMO, Compliance, CRUs, ORC, and senior management to review progress and assist in improving organizational performance as it relates to the study start-up and charge review processes.

Lead the Duke Office of Clinical Research effort to maintain compliance and regulation standards. Monitor compliance through formal and informal processes. Oversee investigation of errant charges and provide feedback to the School of Medicine and the PRMO on any necessary changes or enhancements to the billing protocol; request changes to the billing protocol as appropriate and follow up with study teams to ensure that the updated timeline is applied to active participants.

Monitor new legislation or changes in regulations that might affect the Institution's compliance in regards to clinical research billing, review and revise administrative policies and procedures, as appropriate. Work with DUHS Finance, Compliance, Procurement and the PRMO to ensure research processes are correct and up-to-date.

Collaborate with research applications support team to communicate business and research needs and plan for resources around infrastructure requirements, specifically as pertains to billing, data validation, and research support metrics reporting.

Assist the Associate Dean for Clinical Research with special projects related to study start up, financial and research charge processes.

Perform other related duties incidental to the work described herein.

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Required Qualifications at this Level
Education/Training: Bachelor's degree in a scientific, allied health or related field of study.
Experience: Minimum of five years of experience with management of research staff, experience with grant proposals and budget development, experience with REDCap software implementation and data management skills. At least one year of experience in proven leadership and effective management of the work of a large staff. General knowledge of internal and external research compliance regulations.
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Preferred experience with clinical management of research staff, experience with study start up processes, coverage analysis determination and research billing compliance.

Skills: Strong communication skills, both oral and written. Strong organizational skills
Experience with iRIS, OnCore, Maestro Care and REDCap strongly preferred

The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position.
Employees may be directed to perform job-related tasks other than those specifically presented in this description.

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions

Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

Minimum Qualifications

Education

Bachelor degree in a scientific, allied health or related field of study. Master degree preferred.

Experience

Minimum of seven years of experience with management of research staff, Skills: The intent of this job description is to provide a representative and declaration of the total of the specific duties and responsibilities of experience with grant proposals and budget development, experience with REDCap software implementation and data management skills. At least one year of experience in proven leadership and effective management of the work of a large staff. General knowledge of internal and external research compliance regulations. level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a any particular position. Employees may be directed to perform job- related tasks other than those specifically presented in this description. Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individuals age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status. Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are have a responsibility to uphold these values. respected, and that all voices are heard. All members of our community

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
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