Job Abstract

Job Description

Ensures research compliance with federal, state and institutional policies including development of policies and procedures, auditing of research practices, development of corrective plans, involvement in education and training programs, and the establishment of a collaborative effort to communicate best practices in research compliance throughout the organization.

Job Responsibility

• Manages the development of a research compliance billing program; produces a written plan of activities, addressing research compliance areas, with implementation plans.
• Ensures implementation and evaluation of research billing policies and procedures; reviews policies and procedures for consistency with applicable regulations and professional standards; collaborates with research administration leadership and others in making suggestions for change as needed.
• Participates in assessment of research compliance risk areas and assists with billing/documentation compliance and regulatory risk assessments; develops, implements, and oversees audit compliance program relating to research conduct, integrity, privacy, conflict of interest, export controls or billing and financials in research.
• Determines audit objectives, scope, and procedure, audits ongoing research studies to ensure practices are consistent with applicable regulations, policies, departmental standards, and regulatory approvals.
• Reviews data, such as claims detail, coding billing, and medical and research record documentation to determine compliance with appropriate coding and documentation or study conduct requirements.
• Drafts reports detailing audit findings and communicates with research stakeholders.
• Promotes overall compliance with research billing through participation in education and training activities for professional staff; conducts research, interprets and communicates federal and state laws and guidelines pertaining to Medicare and NYS Medicaid.
• Provides general compliance education and support to audit and facility staff involved in research billing activities; focused training based on results of compliance audits and self-assessments.
• Collaborates with internal audit, and faculty practice and corporate compliance to minimize overlap in compliance activities.
• Operates under general guidance and work assignments are varied and require interpretation and independent decisions on course of action.
• Performs related duties as required. All responsibilities noted here are considered essential functions of the job under the Americans with Disabilities Act. Duties not mentioned here, but considered related are not essential functions.Manages the development of a research compliance program, addressing a comprehensive range of compliance issues, such as human subject protection, animal care, conflict of interest, financial disclosure and the responsible conduct of research; manages the development of a broad scope approach to research compliance; produces a written plan of activities, addressing each of the four major areas of research compliance, with implementation plans Reviews policies and procedures for consistency with applicable regulations and professional standards; collaborates with research administration and others in making suggestions for change as needed; participates in assessment of research compliance risk areas; assists in the identification and sharing of best practices in research compliance.
• Develops, implements, and oversees audit compliance program related to human subjects in research; participates in determining audit objectives, scope, and procedures; audits ongoing human research protocols to ensure practices are consistent with applicable regulations, policies, departmental standards, and regulatory approvals.
• Coordinates the communication and resolution of compliance issues with principle investigators, including a plan of correction; provides detailed reports on audit activities and findings; participates in oversight of financial compliance on all extramurally funded research projects.
• Serves as a liaison between departments regarding financial compliance issues; communicates to investigators about existing policies and procedures related to financial disclosure; provides compliance support, as needed.
• Develops and institutes appropriate plans of corrective action regarding non-compliance issues; assists in education of all principle investigators and other staff on disclosure and reporting requirements.
• Participates in activities related to the responsible conduct of research; reviews existing policies and procedures related to research conduct for consistency with existing regulatory and professional standards.
• Participates in any inquiries or investigations related to allegations of scientific misconduct; promotes overall compliance with ethical research conduct through participation in education and training activities for professional staff.
• Collaborates with key departments throughout the organization to develop appropriate education and training sessions for investigators and clinicians involved in research; monitors participation of research staff in required education programs.
• Operates under limited guidance and work assignments involve moderately complex to complex issues where the analysis of situations or data requires in-depth evaluation of variable factors.
• Performs related duties as required. All responsibilities noted here are considered essential functions of the job under the Americans with Disabilities Act. Duties not mentioned here, but considered related are not essential functions.

Preferred Skills

• Knowledge of COISmart, COI disclosures, COI in research

Job Qualification

• Bachelor's Degree required, or equivalent combination of education and related experience.
• 3-5 years of relevant experience, required.

*Additional Salary Detail
The salary range and/or hourly rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future.When determining a team member's base salary and/or rate, several factors may be considered as applicable (e.g., location, specialty, service line, years of relevant experience, education, credentials, negotiated contracts, budget and internal equity).