Kathy Kemp Email & Phone Number

My initial assignment involved optimization of the internal audit program for the CRU, CRO and Core Laboratory. In July 2021 I assumed responsibility for leadership of the entire Quality Assurance department. In addition to the audit program, responsibilities included hosting regulatory inspections and sponsor audits, evaluation and update of privacy policies, evaluation and update of computer software validation policies and procedures, oversight of business continuity and disaster recovery testing, evaluation and maintenance of the QMS program including the quality issue/CAPA process.

As a Senior QA Manager I conducted various types of internal and external compliance audits of clinical research activities in support of global clinical trials. I also participated in the GCP and compliance training program and assist with development of SOPs and processes.

• Conducted internal quality assurance audits of clinical, laboratory, regulatory, project management and data management activities, ensuring compliance with federal regulations and company policies/procedures.• Conducted vendor audits and audits of contracted clinical research facilities, verifying compliance with industry requirements.• Facilitated client and regulatory agency audits, preparing audit responses and tracking corrective actions to completion.• Maintained MasterControl electronic procedure system and manage procedure revision process, ensuring procedures reflect regulatory requirements, actual practice and revisions processed expeditiously.• Standardized clinical operations across 2 research sites, improving patient safety and accuracy of clinical data.• Developed, implemented and provided ongoing support for Early Clinical Research training program, creating and maintained training matrix, training materials, documentation, and preceptor program.

• Directed start-up and ongoing screening and operations activities of an 80-bed clinical research facility in Denver, Colorado. Provided oversight of 55 clinical studies conducted in healthy-normal and patient populations. Managed 20 staff members including RNs, Paramedics, Research Assistants, Laboratory Assistants and supervisory staff in clinic and laboratory. • Conducted GCP, SOP, and skills training and protocol-specific training, for clinic staff by creating self-study materials, classroom presentations, and mock studies.• Developed processes, programs, and tools, to ensuring clinical conduct team was prepared for and conducted studies according to protocols.• Established robust equipment program, securing data collection accuracy.• Hosted client audits of clinical studies and general clinical operations, providing written responses to audit observations.

• Performed site qualification visits, study initiation visits, interim monitoring visits and closeout visits at clinical investigator sites.• Conducted GCP training for Radiant Development staff.• Developed and updated SOPs for the CRO.

• Directed daily operations of a 70-bed research facility. Provided oversight of 55 clinical studies successfully conducted in healthy-normal and patient populations. Managed 25 staff members across regulatory, recruiting, screening, study conduct and data management departments. • Developed and maintained standard operating procedures for the clinic. Implemented processes for efficient study start-up, recruitment and data management.• Evaluated protocol feasibility and provided input to principal investigators on accept/reject decisions. Developed relationships with area physicians to provide investigator coverage in specialty areas.

• Developed and maintained standard operating procedures and quality management programs for the Phase I clinics acquired from Radiant Research.• Assisted with the start-up of Phase I sites and mentored clinic staff as they conducted their first studies.• Performed quarterly process audits at six Phase I sites and consulted with management on corrective actions as needed.• Monitored monthly quality measures and evaluated the need for new or revised processes or procedures.

• Worked closely with clinical operations staff to formalize and advance their quality systems.• Performed process and data audits to confirm protocol compliance.• Maintained systems for equipment calibration, validation and maintenance.• Drafted new or revised SOPs and assisted training coordinators with revisions to training plans.• Hosted FDA and client audits, prepared audit responses and followed corrective actions to completion.