Maintains general knowledge of all Divisional processes and data elements. Manages all Quality Assurance programs as directed by the Service Line Executive Team. Identifies issues and trends, analyzes data, proposes solutions, keeps statistics and reports to management for performance improvement opportunities. Provides input to identify quality and process improvement opportunities within all Divisional Service Lines. Reviews all Service Line credentialing Processes and works collaboratively with the credentialing team to develop Quality Assurance metrics and benchmarks. Investigates and responds to Quality Assurance inquiries, problems, questions or requests in timely and professional manner to ensure resolution and positive Quality Assurance. Documents appropriate information on computer system based upon department documentation standards. Handles critical workloads and/or department special projects as assigned. Processes assigned reports. Demonstrates ongoing competency skills. Demonstrates above level problem solving skills and decision−making abilities. Demonstrates knowledge of various regulatory agencies. Performs other duties as assigned.

Responsibilities included reviewing protocols, informed consents, CRFs, and study reports.Collaborated with leadership, investigators, HRPP, and IRB to ensure compliance and safety inhuman subject research. Conducted in-clinic monitoring visits, audited clinical trial master filesfor protocol and GCP/ICH compliance, and monitored internal and alternative sites (Dallas,Phoenix, China, and Japan), documenting non-conformities and corrective actions. Assisted withmaintaining Quality Systems and ensuring regulatory compliance, managing technical tasks suchas audit trails, backup activities, and change control monitoring. Developed and maintainedSOPs, contributing to new SOP creation through technical writing. Additionally, qualified vendors,contractors, and CROs per GCP/ICH & SGS standards, and prepared and reviewed departmentalSOPs, worksheets, and data forms. Assisted in Institutional Review Board (IRB) submissions. Familiarity with clinical trial management systems (CTMS) and electronic data capture (EDC) systems.

Responsible for ensuring compliance with protocols, federal regulations, industry guidelines, andcompany procedures. Maintain knowledge of Good Clinical Practices (GCP), Standard OperatingProcedures (SOP), and federal regulations. Oversee clinic safety, ensuring orderly conduct andtaking prompt corrective action for reported or observed unsafe conditions, practices, orequipment. Encourage prompt reporting of health and safety concerns. Reviewed Case ReportForms (CRFs) throughout studies to ensure accuracy from start to finish.

Perform daily clinic and administrative tasks to assist the clinic staff with the studies (i.e. test material preparation, appointment reminders, a quality check of study documents, Electronic Self-Assessment Questionnaire administration, Check-In Process, Informed Consent Signing). Perform station and instrumentation duties on other studies as assigned, including the collection and recording of clinical information. Perform tasks according to Good Clinical Practice (GCP) Guidelines, applicable regulations, Standard Operation Procedures (SOP), and Work Instructions