Research Compliance Specialist

4 weeks ago

Providence, Rhode Island, United States Lifespan Corporation Full time
Job Summary:

The Research Compliance Specialist will be responsible for reviewing research participant billing in compliance with all applicable regulations, guidelines, and policies related to research billing.

This role involves a timely and detailed review of research billing to ensure accuracy and adherence to sponsor agreements, institutional policies, and regulatory requirements.

The specialist will work closely with clinical research teams, finance departments, and CTO manager to maintain integrity and transparency in all billing practices associated with research studies.

Additional responsibilities related to billing compliance to meet the needs of the department.

Consistently applies the corporate values of respect, honesty, and fairness and the constant pursuit of excellence in improving the health status of the people of the region through the provision of customer-friendly, geographically accessible, and high-value services within the environment of a comprehensive integrated academic health system.

Is responsible for knowing and acting in accordance with the principles of the Lifespan Corporate Compliance Program and Code of Conduct.


Key Responsibilities:

Regulatory Compliance:

Perform research billing review in compliance with federal, state, and institutional regulations and policies related to clinical trial billing, including Medicare Coverage Analysis (MCA), National Coverage Determinations (NCD), and Clinical Trial Policy (CTP).

Stay current with changes in billing regulations and guidelines affecting clinical research.


Billing Review and Audits:
Conduct pre-billing reviews of clinical trial charges to ensure accuracy and compliance with contractual agreements.

Identify and report compliance issues and assist CTO manager in developing and implementing corrective action plans.


Education and Training:
May provide training and support to clinical research staff on billing compliance and regulatory requirements.
Documentation and Reporting:
Maintain comprehensive and accurate documentation of billing compliance activities.

Utilize existing EMR reporting to support improved workflows and inform CTO manager of billing compliance status, issues, and resolutions.


Collaboration and Communication:
Collaborate with clinical research coordinators, investigators, finance, and legal departments to ensure accurate billing practices.

Serve as the primary point of contact for billing compliance queries and issues and escalate to the CTO manager as necessary.

Foster a culture of compliance and integrity within the clinical research billing process.


Process Improvement:
Identify opportunities for improving billing compliance processes and systems.

Participate in the development and implementation of new policies and procedures to enhance billing compliance.

Additional Responsibilities

May include as per the needs of the department:

Sponsor invoicing

Review outsourced MCA for accuracy and completeness in line with institutional specifications

Monitor the IRB submission platform for new applications and assess them to determine if an EPIC entry for research billing review is necessary.

Monitor the IRB submission platform for protocol amendment submissions and evaluate whether adjustments to the MCA or sponsor budget are necessary.


Requirements:

Education:
Bachelor's degree in healthcare administration, finance, business, or a related field.
Experience:
Minimum of 3 years of experience in clinical trial billing, healthcare billing compliance, or a related field.

Extensive knowledge of clinical trial billing regulations and guidelines.


Skills:
Understanding of clinical trial lifecycle.

Excellent analytical skills with attention to detail.

Proficient in the use of billing and compliance software systems.

Experience with EMR and/or CTMS system required; EPIC and OnCore experience a plus.

Strong organizational and time management skills.

Excellent communication and interpersonal skills.

Ability to work independently and as part of a team.


Certifications:
Clinical Research Professional Certification or related certification is a plus.
Work Environment and Physical Requirements:
Remote work. Ability to travel to on-site location for occasional team meetings/team building activities a plus but not required.

Sits, stands, and walks intermittently throughout the day.


Independent Action:
Performs independently within department policies and practices.

Refers specific complex problems to supervisor where clarification of department policies and procedures may be required.

May recommend policy or procedural modification.


Lifespan is an Equal Opportunity / Affirmative Action employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, ethnicity, sexual orientation, ancestry, genetics, gender identity or expression, disability, protected veteran or marital status.

Lifespan is a VEVRAA Federal Contractor.


Location:
Rhode Island Hospital
USA:

RI:
Providence
Work Type:
Full Time
Shift:
Shift 1
Union:
Non-Union
Lifespan Corporation

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