Casey Kappenman, Ms, Ccrc Email & Phone Number

Houston, Texas, United States

Serve as the administrative and strategic leader for research operations including the management of 200 faculty, post-docs, and research staff.1) Strategic Leadership and Management:a) Direct the strategic planning, development, and execution of departmental goals and objectives.b) Provide leadership and guidance to a team of approx. 200 employees (clinical research & basic science), fostering a culture of excellence and continuous improvement.2) Financial Oversight:a) Develop and manage the department's $16M budget, ensuring alignment with institutional goals and compliance with funding requirements.3) Operational Excellence:a) Ensure seamless operations across all research activities, including clinical trials, laboratory research, and translational studies.i) Designed and implemented a new Study Activation process to reduce activation times by 40%.4) Human Resources and Staff Development:a) Oversee recruitment, training, and performance management of staff, ensuring the department attracts and retains top talent.5) Regulatory and Compliance:a) Ensure all research activities comply with institutional, state, and federal regulations, including IRB, FDA, ICH, GCP, and NIH guidelines.6) Collaborative Partnerships:a) Foster strong collaborative relationships with internal and external stakeholders. b) Represent the department in various institutional committees and external forums.7) Innovation and Improvement:a) Drive initiatives to advance the department’s research capabilities, including the adoption of cutting-edge technologies and methodologies.b) Lead quality improvement projects aimed at enhancing operational efficiencies. i) Structure operational data to improve analysis and reporting: (1) Standardizing use of OnCore CTMS system for all trial types. (2) Implementing Trello project management to capture study activation performance. (3) Creation of Dashboards to benchmark internal and institutional performance.

Houston, Texas, United States

• Provides strategic leadership and oversight of clinical research operations throughout the trial lifecycle for federal and industry-funded biologic, device, drug, and PI-initiated studies. • Extensive experience identifying and addressing operational bottlenecks and inefficiencies between Texas Heart Institute and research collaborators at Baylor St. Luke’s Medical Center, and Baylor College of Medicine. • Develops performance improvement strategies to optimize complex inter-organizational research processes through workflow analysis and change management methods.• Oversee the integrity and management of technologies such as Clinical Trial Management (CTMS) and electronic regulatory (eReg) systems to support research operations and maintain financial compliance for internal and external partners.• Effective communicator with C-suite executives, administrators, clinicians, staff, and patients.

Houston, Texas Area

Manage the performance of assigned projects including activities related to the market analysis, requirements definition, selection, implementation and monitoring of clinical research technology systems. Responsible for pre-implementation analysis and workflow re-designs affecting business and operational processes, and for measuring the effectiveness of post-implementation strategies to enhance the usefulness of existing applications. Manages and oversees budget development and research billing compliance through processes such as cost and coverage analysis'.

Houston, Texas Area

• Project managed start-up processes on biologic, drug, and medical device studies. Applied workflow analysis to shorten study activation times. • Developed cost analysis process to improve cost recovery and strengthen budget development. • Administrator for institutional CTMS (Clinical Trial Management System).• Serve as liaison between Administrative, Operational and Finance leaders to identify and make changes to workflows in need of process improvement. • Proficient in clinical research regulations.

Houston, Texas Area

Greater Nashville Area, Tn

Primary coordinator for 10+ phase II-IV cardiovascular studies. Wide range of CV clinical research experience including biologics, medical devices, interventional cardiology, pharmaceutical trials.In addition to continually seeking an optimal balance between study objectives and business objectives, the current role requires skills as a liaison, serving to build successful relationships between clients and SCRI.

Houston, Texas Area

• Primary site coordinator for NIH sponsored Cardiovascular Cell Therapy Recruitment Network (CCTRN) – acute myocardial infarction, chronic congestive heart failure, peripheral vascular disease adult stem cell trials.• Serve as site representative for the CCTRN recruitment committee. • Oversee regulatory compliance in accordance with ICH and GCP guidelines.• Responsible for reporting to IRBs, sponsors and Pis.• Prepare trials for internal and external audits.• Aid in the creation and orientation of clinical research satellites facilitating a self-sustaining patient referral network.• Actively recruit/screen subjects while providing patient education and communication with various hospitals and physician offices. • Perform and maintain the informed consent process. • Manage patient follow-up visits.• Direct research assistants, scheduling staff, hospital staff, etc. regarding protocol specific duties.• Provide in-services for hospital departments and various patient support groups interested in the field.

• Pacemaker/AICD/CRT device management in both inpatient and outpatient clinic settings.• Dialogue with electrophysiologists/cardiologists regarding proper function and outcomes of device therapies.• Analysis of diagnostics to troubleshoot or reprogram devices for various medical interventions while adhering to hospital policy and patient safety guidelines. • Provide education/orientation to new cardiology fellows. • Explain device function(s), testing protocol and follow-up to patients and various health care disciplines.• Provide education to patients regarding life after implant and post-implant precautions. • Assist in managing a database of over 11,000 patients’ device implants, libraries, tests and follow-up orders.

Master'S, Applied Biomedical Informatics

B.S., Exercise Physiology

Bachelor Of Science (B.S.)