The Research Compliance Business Partner 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.
The position reports to the Director of Ethics and Compliance.
* 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
* Observe regulatory and sponsor audits and support investigators and study teams as necessary during these 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; assist in the development of corrective actions and written responses as warranted
* 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 for large audiences and topic specific sessions for small audiences or individual researchers
* Chair Research Compliance Committee and participate as member of the Financial 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
* 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
Required: Bachelor's degree in science- or audit/compliance-related field or equivalent years of experience
Preferred: Advanced degree
Industry-recognized Compliance Auditor certification, Clinical Research Professional certification, or equivalent certifications preferred
* Minimum of 5 years in a relevant position (i.e., as a manager; coordinator; regulatory; or quality compliance position)
* Previous FDA or sponsor monitoring experience preferred
Bachelor's Degree (Required)
Day (United States of America)
"The best place to get care. The best place to give care." That is the Saint Luke's vision and, whether in a hospital, clinic, practice, or office, our more than 12,000 employees strive toward that vision every day. Saint Luke's employees are proud of our rich history and heritage, and that we remain the only faith-based, nonprofit, locally owned health system in Kansas City. Joining Saint Luke's means joining a team of exceptional professionals who always strive for excellence in patient care. Take this opportunity to do the best work of your career within a highly diverse and inclusive work space where all voices matter.
Join the Kansas City region's premiere provider of health services. Equal Opportunity Employer. We hire only non-tobacco users.
Effective November 1st, 2021, full COVID-19 vaccination is a condition of employment for all Saint Luke's Health System employees unless a medical or religious exemption is approved.