Responsible for overseeing all clinical research quality assurance functions within Saint Luke's Health System (SLHS). Ensures planning, coordination, management, establishment and continuous improvement of processes and procedures to assess and monitor the conduct and quality of studies conducted at SLHS. Focuses on continuous improvement projects using approved tools, design control, and validations to ensure adherence to the agency regulations, industry guidelines, local regulations, along with SLHS clinical policies and procedures for the conduct of clinical trials.
* Develop and maintain GCP/ICH compliant procedures and processes which monitor the quality of clinical research studies conducted at SLHS
* Actively lead and/or assist activities in the areas of internal quality audits, CAPA (Corrective and Preventive Actions), and quality management reviews
* Supervise and/or lead internal audit activities to ensure that studies are conducted in accordance with sponsor protocols, GCP, industry guidelines, and regulatory agency standards
* Supervise and/or lead audits of external vendors and sites
* Assist with management of auditors
* Supervise and/or lead activities related to any external audits of SLHS research activities by sponsors and regulatory agencies
* Identify non-conformance with requirements, provide suitable recommendations and facilitate ongoing quality improvements using risk-based methodology while maintaining compliance with applicable study protocols, Quality System Regulations and or ISO standards where applicable
* Supervise and/or lead review of monitoring reports and track CAPAs to completion, escalating important events to senior management
* Assist in providing training to clinical research staff and documenting this training
* Assist with recruitment and retention of quality assurance staff
* Review vendor supplied data and quality records for conformance and good documentation practices (GDP)
* Support special projects requiring QA input
* Participate in the review and installation of technology products and equipment to support clinical research infrastructure
* Monitor and track the review cycle of policies and procedures relevant to clinical research
* Perform other related duties as assigned
* American Society for Quality, Auditor, or Certified Clinical Research Professional (Association of Clinical Research Professionals or Society of Clinical Research Associates) certification highly desirable
* In-depth knowledge of US, EU and International regulatory standards, and GxP guidelines for the conduct of clinical trials
* Experience including external/CRO, clinical/regulatory and document auditing highly desirable
* At least 5 years' working in a Quality Control / Assurance area
Bachelor's Degree (Required)
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. 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.