Throughout the COVID-19 pandemic, Saint Luke’s Health System is committed to providing exceptional care for all patients and a safe and healthy atmosphere for our team.

Person, Nurse, Doctor

Director Research Quality Assurance and Clinical Trial Operations, Full Time.

Kansas City, Missouri.

JobReq0024815

 

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Director Research Quality Assurance and Clinical Trial Operations

  • 4401 Wornall Rd, Saint Luke's Hospital of Kansas City, Kansas City, Missouri, United States, 64111
  • Research Job Family
  • Full Time

Job Description​

Responsible for overseeing all clinical research quality assurance functions within Saint Luke’s Health System (SLHS). Responsible for supervising all aspects of clinical trial operations (including research coordination, quality and regulatory compliance, among others). 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. Actively supervises project management and coordination of activities relating to multi-center investigator-initiated trials sponsored by Saint Luke’s. 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. 

Essential Duties and Responsibilities:
• 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 staff in the areas of quality assurance and clinical trial operations
• Supervise, and lead efforts to expand and harmonize clinical trial operations at SLHS, with a focus on multi-centered trials sponsored by Saint Luke’s
• 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

Education and Experience:
• Bachelor’s Degree in associated functional discipline
• In-depth knowledge of US, EU and International regulatory standards, and
GxP guidelines for the conduct of clinical trials
• At least 5 years’ working in a Quality Control / Assurance area
• At least 5 years of experience in clinical trial operations
• American Society for Quality, Auditor, Clinical Trial Associate or Clinical Trial Manager accreditation highly desirable
• Experience including external/CRO, clinical/regulatory and document auditing highly
desirable

Job Requirements

Applicable Experience:

3-5 years

Bachelor's Degree (Required)

Job Details

Full Time

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.

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