Job DescriptionThe OpportunitySaint Luke's Hospital is looking for a Research Compliance Business Partner who will assist in the overall management of regulatory compliance for the Research Program at Saint Luke's Health System. The position is responsible for monitoring and auditing research-related activities (including clinical, billing, privacy, IRB, and data/information management) and working collaboratively with investigators, study staff, research business office and IRB staff, and others to ensure compliance with institutional policies, industry standards, and applicable law and guidance. Our priority is patient care in that we interact with patients daily and have the opportunity to bring something positive to their day to ensure Saint Luke's is
"The Best Place To Get Care, The Best Place To Give Care." Specific Responsibilities- Function as a highly visible business partner to address ethics, compliance and privacy issues related to the Research Program
- Conduct annual research risk assessment; prepare and execute an annual research compliance management plan based on risk assessment
- Conduct and/ or work with outside consultants to conduct for-cause audits of research activities (e.g., in response to specific identified issues, or as requested by the IRB or institutional officials)
- Conduct follow-up and monitor progress on audit recommendations and corrective action plans
- In collaboration with the Research Quality Assurance Manager:
- Observe regulatory and sponsor audits as necessary
- Support investigators and study teams as necessary during regulatory and sponsor audits;
- Assist investigators and the organization in preparation for external audits and inspections;
- Interview personnel and review records in advance of audits/inspections to identify and proactively address possible areas of concern;
- Conduct follow-up and monitor progress on audit recommendations and written responses
- Assist in the development of corrective and preventive actions and monitor for progress and completion
- Develop, review, and revise Standard Operating Procedures and checklists/tools to be utilized when conducting compliance reviews or audits
- As time permits, conduct random, periodic, not-for-cause audits of human subjects studies and IRB activities to assure compliance and identify non-compliance with applicable law and guidance and institutional policies and procedures
- Design, develop and provide communications, training, and education to the research community, including general research compliance educational sessions
- Coordinate, and participant as a member of, the Research Compliance Committee and the Research Conflict of Interest Committee
- Attend IRB meetings to help support compliance with applicable law and guidance and institutional policies and procedures
- Assist in the creation of metrics to report to senior management and prepare written reports of research compliance activities and trends, including monitoring and auditing efforts, to leadership
- Monitor changes to, interpret, analyze, and apply applicable law and guidance, standards, and best practices, along with institutional policies and procedures, that support ethical and compliant research practices are followed
- Act as the research compliance liaison to assist the Corporate Compliance Department in implementing and overseeing the BJC Compliance Program by providing assistance as directed by Corporate Compliance in investigating and responding to compliance questions and issues regarding research.
Competencies- Knowledge of and ability to apply relevant federal regulations and institutional policies and procedures relating to human subjects research and IRB review
- In-depth knowledge and experience in the application of Good Clinical Practice (GCP), FDA and OHRP regulations and guidance, and HIPAA, 21 CFR Part 11, and GDPR requirements related to research
- Knowledge of clinical research procedures, clinical trial compliance monitoring, auditing and/or investigations, and research billing regulations and best practices
- Ability to interact directly with institutional executive leadership, investigators, research staff, members of various health system departments, and outside consultants
- Proven ability to work within established policies and procedures to gather and interpret research-related information, identify potential or actual problems, formulate possible solutions, take appropriate actions to resolve the issues/problems, and evaluate results or progress
- Familiarity with quantitative and qualitative research design, scientific research and terminology, and the essential documents related to clinical research studies
- Ability to communicate issues and progress effectively and receive guidance on complex problems or issues
- Ability to handle confidential matters by exercising good judgment and discretion
- Ability to identify training/education needs
- Computer literacy, word processing, computer entry skills and attention to detail
- Strong written and oral communication skills
- Ability to multi-task
- Excellent organizational skills
- Ability to work with others as well as with relative independence
Job RequirementsApplicable Experience:
6-9 years
Bachelor's Degree
Job DetailsFull Time
Day (United States of America)
The best place to get care. The best place to give care. Saint Luke's 12,000 employees strive toward that vision every day. Our employees are proud to work for the only faith-based, nonprofit, locally owned health system in Kansas City. Joining Saint Luke's means joining a team of exceptional professionals who strive for excellence in patient care. Do the best work of your career within a highly diverse and inclusive workspace where all voices matter.Join the Kansas City region's premiere provider of health services. Equal Opportunity Employer.
