General Information
| Payroll Title | ADM CRD OFCR | Title Code | 000355 | Grade/Step | 7 | Working Title | Chief Clinical and Research Compliance Officer (CCRCO) |
|---|---|---|---|---|---|---|---|
| Department Name | Clinical Affairs Dept | Supervisor | Glenn R Olds | Department Head | Glenn R Olds |
Payroll Title of those supervised
| Title Code | Description | FTE |
|---|---|---|
| 7235 | ANL 2 | 1 |
| 0730 | ANL 5 | 1 |
| 7237 | ANL 4 | 1 |
Special Requirements and Conditions
| Critical Position |
| Travel |
| Travel Outside of Normal Business Hours |
Level of Supervision Received
| General Direction |
Items Used
| Standard office equipment and computers |
Position Purpose
| The UCR School of Medicine (SOM) and the Office of Research at the University of California, Riverside is seeking a highly skilled and experienced Clinical Compliance Officer with demonstrated experience in managing a broad range of compliance functions related to activities relevant to a research intensive, academic, health sciences institution. In 2013, the UCR School of Medicine has enrolled its first class of medical students, is actively recruiting toward expansion of its basic and clinical science research programs, building and soon enrolling trainees in new Graduate Medical Education (GME) programs and is aggressively building clinical programs to expand the delivery of primary and specialty care services throughout the Inland Southern California region. The Chief Clinical and Research Compliance Officer (CCRCO) is a high-level official with direct access to: -Vice Chancellor, Health Affairs, and Dean, School of Medicine; -Vice Chancellor, Research; -CEO of the UCR physician group and leadership of the segments of the clinical enterprise; -Senior Associate Deans of School of Medicine and AVCs of the Office of Research -Leadership of affiliated hospitals and physician groups; -Legal counsel, both internal and external -UCR Local Designated Official (LDO) -Direct access to the Chancellor of UCR and SVP for Compliance and Audit as needed; Reporting directly to both the Vice Chancellor for Health Affairs, (also Dean of the School of Medicine) as well as the Vice Chancellor for Research Affairs at UCR, the position holds a broad range of compliance responsibilities related to Health Affairs which include clinical enterprise, clinical research and related health affairs activities (medical risk management) with the title of Chief Clinical and Research Compliance Officer (CCRCO). The position also has a solid line organizational reporting relationship to the SVP for Compliance and Audit at the UC Office of the President and ability to access the UCR Chancellor as necessary. The CCRCO also reports annually to The Regents through the UC SVP for Health Sciences and Services or his/her designee, and the Senior Vice President/Chief Compliance and Audit Officer which ensures substantial alignment of the UC Riverside SOM clinical compliance program with industry standards, including those at other University schools of medicine and clinical compliance programs. Identify clinical compliance issues, lead projects and policy design, redesign and coordinate internal and external communications, often at the senior executive level ensuring that compliance-related matters are handled in a timely and appropriate way. Oversee and direct the clinical compliance program to ensure that UCR SOM fulfills its academic missions of training, research, clinical care and service through development of programs and processes which aim to prevent fraud, waste and abuse. Please Note: The payroll title for this position is currently under review. |
Essential Functions
| Essential Function | % Time |
|---|---|
| Clinical Compliance | 50 |
| Oversee and monitor the implementation of the compliance program which includes all facets of clinical research and clinical care: Professional Coding/Billing/Collection/Reconciliations: Oversee and report to the governing body and leadership, CEO and compliance committee on the progress of implementation, and assist these components in establishing methods to improve efficiency and quality of services, and to reduce the vulnerability to fraud, abuse, and waste. Periodically revise the Clinical Compliance program in light of changes in the needs of the organization, and in the law and policies and procedures of government and private payer health plans. Review all documents and other information that are relevant to compliance activities, including: data, patient records, billing records, marketing efforts, and arrangements with other parties, including employees, professionals on staff, research sponsors, insurers, non-health system health care providers, independent contractors, suppliers, and agents, etc. This enables the CCRCO to review contracts and obligations (seeking the advice of legal counsel, where appropriate) that may contain referral and payment issues that could violate the anti-kickback statutes, as well as the physician self-referral prohibition and any other legal or regulatory requirements. Training: Develop, coordinate, and participate in a multifaceted educational and training programs that focus on the elements of the overall components of the Clinical professional services and Clinical Research compliance programs, seeking to ensure that all appropriate employees and management are knowledgeable of, and comply with, pertinent federal and state standards. Ensure that independent contractors and agents who furnish medical services to the health system are aware of the requirements of the compliance program with respect to coding, coverage, billing, and marketing, among other things. Human Resources: Ensure through the human resources office, the vice chancellor and dean's office, the purchasing department and the credentialing office that the Cumulative Sanction Report and GSA Excluded Parties System have been checked with respect to all employees, medical staff, and independent contractors. Monitoring: Working along with campus Internal Audit, coordinate internal compliance review and monitoring activities, including periodic reviews of departments across the various segments of the overall clinical and research compliance program. Investigations: Respond to government investigations and queries related to clinical professional services or research as the principal point of contact. Independently investigate and act on matters related to compliance, including the flexibility to design and coordinate internal investigations (e.g., respond to reports of problems, 'hot-line' calls, or suspected violations) and resulting corrective actions with all health system departments, providers and sub-providers, agents and, if appropriate, independent contractors. Respond promptly to detected offenses, developing corrective action, and reporting findings to the government via established channels; Develop policies and programs that encourage managers and employees to report suspected fraud without fear of retaliation. Implement written policies, procedures, and standards of conduct. Establish, convene and maintain a compliance committee(s) relevant to the school of medicine and its clinical enterprise; Enforce standards through well publicized disciplinary guidelines and developing policies addressing dealings with sanctioned individuals; Review and advise on issues related to Professional Service Agreements (PSA). Conduct periodic risk assessments and response plans; Standing ex-officio Clinical Committee memberships: Advisory Committee to the Dean on Compensation and Conflicts of Interest/Commitment, Clinical services Audit Committee. |
|
| Clinical Research Compliance | 30 |
| Budget and Financial Management: -Review all proposals for appropriate start-up costs (IRB preparation and review fees, hospital charges, sponsor interactions, training of research coordinators); -Identify all potential study-related costs (ensure that revisions are incorporated re sponsor negotiations and Medicare Coverage Analysis); -Open study accounts; -Monitor study expenditures and receipts, oversee study account reconciliation -Coordinate with SOM service center to ensure appropriate invoicing/billing with clinics/hospitals/physicians/partners -Monitors effort on study; -Monitors closure of funding at study conclusion. Contracts: -Subject Injury language/consent forms -Reviews and approves contract language to ensure that Subject Injury language and consent form are consistent; -Determination of Medicare Qualification as a Medicare qualifying trial; -Reviews and approves identifiable costs -Monitors protocols to approvals, and checks for ongoing quality assurance for adherence to approved protocols; conducts random audit checks, and provides continuous education to research coordinators and departments. As appropriate, assist the Institutional Officer (IO) for Clinical and Social/Behavioral Sciences Committees on Human man Research (CHR) Institutional Review Boards (IRB) with responsibilities associated with reviewing protocols and consents, managing annual reviews and amendments, monitoring and reporting on adverse events, serious non-compliance, unanticipated events and other safety issues to HHS Office of Human Research Protection (OHRP) and FDA. Institutional Animal Care and Use Committee (IACUC) - Institutional Officer for animal use and care committees. Stem Cell Oversight: -Reviews and approves all protocols and consents related to Stem Cell use and manages all federal reporting requirements Manages additional Committees including: -Biosafety committee -Willed Body Program (UCR SOM Gross Anatomy program) Establish and administer a process for receiving, documenting, tracking, investigating, and taking action on all complaints concerning research compliance. |
|
| Risk Management | 10 |
| Oversees the development of risk management programs for the health sciences activities of the SOM, develops and conducts risk assessments, identifies and mitigates specific risk issues. Reviews and advises on provisions required in professional service agreements (PSA). Other duties as assigned. |
|
| Privacy Officer | 10 |
| Oversee all ongoing activities related to development, implementation, maintenance of, and adherence to UCR policies and procedures covering privacy of and access to protected health information (PHI) in compliance to federal and state laws and health system privacy practices. This is accomplished by: Ensuring that periodic risk assessments and ongoing monitoring of key elements of the privacy program are monitored; including privacy notice, consent, authorization, business partner agreements/practices, minimum necessary information and disclosure are conducted; Providing development guidance and assistance in the identification, implementation, and maintenance of organization information privacy policies and procedures in coordination with senior management the HIPAA committee and UCOP; Serve in a leadership role for the HIPAA Committee's activities; Perform initial and periodic information privacy risk assessments and conducts related ongoing compliance monitoring activities in coordination with UCR's other compliance and operational assessment functions; Work with legal counsel and management, key departments, and committees to ensure the organization has and maintains appropriate privacy and confidentiality consent, authorization forms, and information notices and materials reflecting current organization and legal practices and requirements; Oversee delivery of initial privacy training and orientation to all employees, volunteers, medical and professional staff, contractors, alliances, business associates, and other appropriate third parties; Participate in the development, implementation, and ongoing compliance monitoring of all trading partner and business associate agreements, to ensure all privacy concerns, requirements, and responsibilities are addressed; Establish a mechanism to track access to PHI, within the purview of the organization and as required by law and to allow qualified individuals to review or receive a report on such activity; Work cooperatively with information technology units (including SOM, Research, campus, etc.) in overseeing patient rights to inspect, amend, and restrict access to PHI when appropriate; Establish and administer a process for receiving, documenting, tracking, investigating, and taking action on all complaints concerning privacy policies and procedures; Ensure compliance with privacy practices and consistent application of sanctions for failure to comply with privacy policies for all individuals in the organization's workforce, extended workforce, and for all business associates; Initiate, facilitate and promote activities to foster information privacy awareness within the organization and related entities; Review all system-related information security plans throughout the organization's network to ensure alignment between security and privacy practices, and act as a liaison to the information systems department; Work with all organization personnel involved with any aspect of release of PHI, to ensure full coordination and cooperation under the organization's policies and procedures and legal requirements; Maintain current knowledge of applicable federal and state privacy laws and accreditation standards, and monitor advancements in information privacy technologies to ensure organizational adaptation and compliance; Serve as information privacy consultant to the organization for all departments and appropriate entities; Cooperate with the Office of Civil Rights, other legal entities, and organization officers in any compliance reviews or investigations; Work with administration, legal counsel, and other related parties to represent the organization's information privacy interests with external parties (state or local government bodies) who undertake to adopt or amend privacy legislation, regulation, or standard. |
|
Minimum Requirements
| Minimum Requirement | Display Ranking |
|---|---|
| 1 | |
| Advanced degree in business administration, healthcare administration, or law or a related field or an equivalent combination of education and experience. Minimum 7 years of advanced progressive experience in managing compliance and privacy programs and operations at a campus or organizational level in a research university setting. Priority consideration will be given to those candidates who have demonstrated UC experience managing compliance and privacy programs at a campus or organizational level. Demonstrated experience working in a research university academic teaching environment and understanding of the complexities of the clinical, research, and teaching roles of the faculty in a School of Medicine. Experience in the development of innovative and creative measures required in, or by a new, emerging medical school or growing health sciences research organization in a research university setting. Demonstrated leadership experience in planning, managing risk, and policy development. Demonstrated skill in evaluating project needs, determining approaches, evaluating impact of alternatives and making viable recommendations consistent with sound risk management principles. Expert knowledge of clinical and clinical research regulatory environments and issues. Knowledge and recent experience with the major trends that are affecting clinical, research, and teaching enterprises in order to position the School in the most advantageous way. Demonstrated understanding of how to achieve results in an academic environment. Ability to effect resolution of challenges that requires experience, informed analysis, and ingenuity to develop viable solutions. Proven ability to function effectively in a complex, dynamic, environment, with demonstrated success in building effective and productive relationships. The ability to work with Academic Leadership, physicians, staff and professionals in multiple settings and locations and to promote compliance programs and activities Advanced computer proficiency. Exceptional oral and written communication skills; ability to present ideas orally and in writing to a variety of audiences in a professional and logical manner with supporting documentation. Demonstrated supervisory experience and ability to function productively and synergistically as part of, and leading, a team of professionals. Hired candidate must successfully complete a background check through the U.S. Department of Justice. |
|
Preferred Qualifications
| Preferred Qualification | Display Ranking |
|---|---|
| 1 | |
|
Terminal degree in business administration, healthcare administration, or law or a related field or an equivalent combination of education and experience. Compliance related certifications, ie: CHC, CHPC, CCEP, etc. Demonstrated and related leadership experience at the University of California. |
|
| Posted Position Purpose |
|---|
| The UCR School of Medicine (SOM) and the Office of Research at the University of California, Riverside is seeking a highly skilled and experienced Clinical Compliance Officer with demonstrated experience in managing a broad range of compliance functions related to activities relevant to a research intensive, academic, health sciences institution. In 2013, the UCR School of Medicine has enrolled its first class of medical students, is actively recruiting toward expansion of its basic and clinical science research programs, building and soon enrolling trainees in new Graduate Medical Education (GME) programs and is aggressively building clinical programs to expand the delivery of primary and specialty care services throughout the Inland Southern California region.
The Chief Clinical and Research Compliance Officer (CCRCO) is a high-level official with direct access to:
-Vice Chancellor, Health Affairs, and Dean, School of Medicine;
-Vice Chancellor, Research;
-CEO of the UCR physician group and leadership of the segments of the clinical enterprise;
-Senior Associate Deans of School of Medicine and AVCs of the Office of Research
-Leadership of affiliated hospitals and physician groups;
-Legal counsel, both internal and external
-UCR Local Designated Official (LDO)
-Direct access to the Chancellor of UCR and SVP for Compliance and Audit as needed;
Reporting directly to both the Vice Chancellor for Health Affairs, (also Dean of the School of Medicine) as well as the Vice Chancellor for Research Affairs at UCR, the position holds a broad range of compliance responsibilities related to Health Affairs which include clinical enterprise, clinical research and related health affairs activities (medical risk management) with the title of Chief Clinical and Research Compliance Officer (CCRCO). The position also has a solid line organizational reporting relationship to the SVP for Compliance and Audit at the UC Office of the President and ability to access the UCR Chancellor as necessary. The CCRCO also reports annually to The Regents through the UC SVP for Health Sciences and Services or his/her designee, and the Senior Vice President/Chief Compliance and Audit Officer which ensures substantial alignment of the UC Riverside SOM clinical compliance program with industry standards, including those at other University schools of medicine and clinical compliance programs.
Identify clinical compliance issues, lead projects and policy design, redesign and coordinate internal and external communications, often at the senior executive level ensuring that compliance-related matters are handled in a timely and appropriate way. Oversee and direct the clinical compliance program to ensure that UCR SOM fulfills its academic missions of training, research, clinical care and service through development of programs and processes which aim to prevent fraud, waste and abuse.
Please Note: The payroll title for this position is currently under review. |
| Posted Minimum Requirements |
| Advanced degree in business administration, healthcare administration, or law or a related field or an equivalent combination of education and experience. Minimum 7 years of advanced progressive experience in managing compliance and privacy programs and operations at a campus or organizational level in a research university setting. Priority consideration will be given to those candidates who have demonstrated UC experience managing compliance and privacy programs at a campus or organizational level. Demonstrated experience working in a research university academic teaching environment and understanding of the complexities of the clinical, research, and teaching roles of the faculty in a School of Medicine. Experience in the development of innovative and creative measures required in, or by a new, emerging medical school or growing health sciences research organization in a research university setting. Demonstrated leadership experience in planning, managing risk, and policy development. Demonstrated skill in evaluating project needs, determining approaches, evaluating impact of alternatives and making viable recommendations consistent with sound risk management principles. Expert knowledge of clinical and clinical research regulatory environments and issues. Knowledge and recent experience with the major trends that are affecting clinical, research, and teaching enterprises in order to position the School in the most advantageous way. Demonstrated understanding of how to achieve results in an academic environment. Ability to effect resolution of challenges that requires experience, informed analysis, and ingenuity to develop viable solutions. Proven ability to function effectively in a complex, dynamic, environment, with demonstrated success in building effective and productive relationships. The ability to work with Academic Leadership, physicians, staff and professionals in multiple settings and locations and to promote compliance programs and activities Advanced computer proficiency. Exceptional oral and written communication skills; ability to present ideas orally and in writing to a variety of audiences in a professional and logical manner with supporting documentation. Demonstrated supervisory experience and ability to function productively and synergistically as part of, and leading, a team of professionals. Hired candidate must successfully complete a background check through the U.S. Department of Justice. |
| Posted Preferred Qualifications |
| Terminal degree in business administration, healthcare administration, or law or a related field or an equivalent combination of education and experience. Compliance related certifications, ie: CHC, CHPC, CCEP, etc. Demonstrated and related leadership experience at the University of California. |