Clinical manager h1.location_city

St. Luke's is proud of the skills, experience and compassion of its employees. The employees of St. Luke's are our most valuable asset! Individually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care. The Manager of Clinical Research Quality is responsible for the oversight, development, and implementation of the clinical research quality management system across a community hospital system conducting both oncology and non-oncology clinical trials JOB DUTIES AND RESPONSIBILITIES: Oversees the clinical research Quality Management System and its compliance with federal, state, and local, regulations, Good Clinical Practice (GCP), as well as institutional policies and procedures, including IRB and Network Compliance. Chair the department Quality Management Committee, setting agendas, reviewing quality metrics, and guiding process improvement and training efforts. Develop, maintain, and implement department Standard Operating Procedures (SOPs) that are compliant with all applicable regulations, policies, and Good Clinical Practices (GCP). Lead recurring SOP review cycles with document authors, process owners, and subject matter experts, and coordinate ad-hoc updates in response to changes in regulations, GCP, and/or internal policies and processes. Serve as the point person for monitoring for and interpreting new regulations affecting the clinical research process and quality management system and disseminating impact to staff and investigators. Oversees and facilitates the Clinical Trials Office training and education program, delivering role-specific instruction per training matrix on SOPs and research processes, including knowledge assessment and competency checks, to ensure consistent knowledge and compliant research conduct across all study teams, investigators, and supporting departments. Oversee and enhance research readiness process for new investigators and clinical research staff including overall training profiles, initial onboarding, and ongoing compliance with institutional general and role-specific procedural qualifications and training. Responsible for tracking and managing training records for researchers, ensuring documentation of completed training, work with department leaders in identifying retraining needs, and overseeing the delivery and documentation of all retraining activities. Collaborate with organization training departments to enhance technology and training records and compliance documentation. Oversee and manage a risk-based internal quality review program for sponsored and investigator-initiated clinical trials and research, including but not limited to conducting quality reviews of study documentation, regulatory binders, informed consent processes, source documentation, and case report form data. PHYSICAL AND SENSORY REQUIREMENTS: Requires sitting for up to 7 hours per day, 5 hours at a time. Standing for up to 4 hours per day, 3 hours at a time. Requires frequent fingering, handling, and twisting and turning. Occasionally requires lifting, carrying and pushing and pulling objects weighing up to 20 pounds. Occasionally requires reaching above shoulder level. Must have the ability to hear as it relates to normal conversation and seeing as it relates to general vision. EDUCATION: Bachelor’s degree in a health science, life science, nursing, or related field required. Master’s degree preferred. TRAINING AND EXPERIENCE: Minimum of 5 years of experience in clinical research in a monitoring role or at a research site, with at least 2 years in a quality management, regulatory, or compliance role. Clinical Research Certification (e.g., CCRC, CCRP, CCRA) preferred. Subject Matter Expert in ICH-GCP, FDA regulations (including, 21 CFR Parts 11, 50, 54, 56, 312, and 812), and HHS regulations (45 CFR 46). In-depth knowledge of Microsoft Office Programs: Word, Excel, PowerPoint, Outlook; Internet Functions required. Experience with both oncology and non-oncology clinical trials. Previous experience in a hospital-based or health system clinical research environment. Strong organizational and communication skills. Excellent analytical and problem-solving skills. Proficiency in electronic regulatory systems, clinical trial management systems, and other research focused systems. Please complete your application using your full legal name and current home address. Be sure to include employment history for the past seven (7) years, including your present employer. Additionally, you are encouraged to upload a current resume, including all work history, education, and/or certifications and licenses, if applicable. It is highly recommended that you create a profile at the conclusion of submitting your first application. Thank you for your interest in St. Luke's!! St. Luke's University Health Network is an Equal Opportunity Employer.