Lisa Haney Email and Phone Number

• Manages Clinical Quality and Operations for the Coronary and Renal Denervation Clinical Team• Completes audits to assess accuracy and quality of scientific data submitted to the regulatory agencies in support of new drug application, biological licensing agreement, animal drug application or medical devices application.• Conducts and performs investigations and ensures conformance to regulations and company standard operating procedures.• Documents audit observations and makes recommendations for corrective and preventive action.• May create and maintain clinical quality assurance databases, reports, and files.• Performs quality reviews and tracks corrective and preventive actions until closure.• May act as an advisor on clinical quality assurance protocol, amendments and/or biological licensing agreements.• May also audit operating systems, processes, and procedures.• May support risk management operations, including ongoing review of literature and compilation and interpretation of safety data to support product strategies.• May plan and prepare report drafts for products, compliance statements, audit certifications, and safety issues for regulatory submission.• May use six-sigma methodology.• May provide training on GCP and current regulations for those undertaking clinical studies.

• Fulfilled the Quality role and performed Quality responsibilities for the Coronary and Renal Denervation Clinical Team• Completed audits to assess accuracy and quality of scientific data submitted to the regulatory agencies in support of new drug application, biological licensing agreement, animal drug application or medical devices application.• Conducted and performed investigations and ensured conformance to regulations and company standard operating procedures.• Documented audit observations and made recommendations for corrective and preventive action.• Created and maintained clinical quality assurance databases, reports, and files.• Performed quality reviews and tracked corrective and preventive actions until closure.• Acted as an advisor on clinical quality assurance protocol, amendments and/or biological licensing agreements.• Audited operating systems, processes, and procedures.• Supported risk management operations, including ongoing review of literature and compilation and interpretation of safety data to support product strategies.• Planned and prepared report drafts for products, compliance statements, audit certifications, and safety issues for regulatory submission.• Provided training on GCP

• Fulfilled Quality responsibilities as assigned for the legacy Coronary and Structural Heart Clinical Business Unit, and the subsequent Coronary and Renal Denervation Clinical Operating Unit· Completed audits to assess accuracy and quality of scientific data submitted to the regulatory agencies in support of new drug application, biological licensing agreement, animal drug application or medical devices application.· Conducted and performed investigations and ensured conformance to regulations and company standard operating procedures, as well as audit operating systems, processes and procedures.· Documented audit observations and made recommendations for corrective and preventive action (CAPA) plans, as well as conducted quality reviews and tracked CAPAs until closure.

• Conduct internal quality reviews or audits for clinical research sites• Develop presentations and training programs, as well as present on various clinical research topics• Manage professional development training program course development• Select course developers and subject matter experts for the development of professional development courses• Manage the analysis, design, development and delivery of clinical research courses• Provide reviews and/or content for professional development online, classroom, and webinar courses

• In collaboration with clinical Trial Managers oversee daily activities of Clinical Affairs Operations personnel including projects, resources, timelines and budgets through direct line or dual line reporting structure• Identify training platforms and provide mentoring to Clinical Affairs Operations personnel, and determine personnel readiness to complete various operations functions• Ensure compliance with protocols, corporate and divisional standards, procedures, regulations and Good Clinical Practice guidelines, as applicable• Lead efforts to define and streamline Clinical Affairs Operations functions through collaboration with Divisional, Corporate and Lutonix Clinical Affairs Operations personnel as appropriate• Implement and revise Clinical Standards and Work Instructions• Interact with the Divisional and Corporate Management teams to define, implement and execute clinical strategies in support of defined objectives• Develop and maintain collaborative working relationships with Project Teams and other working groups to achieve stated business objectives• Assist Clinical leadership in organizational planning, resource allocation, and oversight of worldwide clinical operations• Provide operational input for the design of clinical protocols and case report forms

Clinical Operations Manager within Lutonix Clinical Affairs department.

Responsibilities• Prepared and facilitated the DSMC quarterly and ad hoc meetings• Facilitated physician review of all SAEs, UAPs and reportable AEs identified within the Cancer Center• Managed the DSMC auditors and conducts audits as needed• Reviewed and signed off on audit reports, as well as tracked audit findings for trends• Developed educational presentations for new clinical research staff and investigators• Reviewed protocol data safety monitoring plans within all CU Cancer Center protocolsKey Accomplishments• Developed and implemented the latest Institutional Data Safety Monitoring (DSM) Plan• Developed a system for identifying investigator initiated protocols requiring DSMC review/audit• Wrote standardized data and safety monitoring plan language for use within investigator initiated protocols • Developed and implemented policies, guidelines and procedures for the DSMC and DSMC audit team• Transitioned monitoring activities out of the DSMC; and developed training and resources for Principle Investigators to monitor their clinical trials per Federal Regulations and GCPs• Developed a DSMC SharePoint site to facilitate quarterly DSMC meetings and archive DSMC materials

Responsibilities• Selected course developers and subject matter experts for the development of professional development courses• Managed the analysis, design, development and delivery of clinical research courses• Provided reviews and/or content for professional development online, classroom, and webinar coursesKey Accomplishments• Delivered two hybrid online and classroom courses on time and within budget • Delivered eight online and courses on time and within budget• Obtained reaccreditation from the Accreditation Council for Continuing Medical Education (ACCME)

Responsibilities • Coordinated with multiple contractors for the development of data collection tools and documents• Coordinated the translation and graphics design of various NCS documents for IRB review and approval• Reviewed study materials and files for compliance with human subject protections regulations•Developed Study protocol amendment packages for IRB review and approval• Reviewed and triaged out proposals for grants supporting novel global health solutions• Reviewed regulatory plans and protocols, and provided recommendations for medical device FDA approval• Conducted routine on-site audits to evaluate proper handling of research protocolsKey Accomplishments• Developed a process for the identification and tracking of questionnaires, case report forms and other data collection documentation required for National Children’s Study (NCS) data collection development process• Developed and maintained a NCS SharePoint pages for data collection tools and documentation• Developed a comprehensive inventory of SOPs, business processes, trainings and guidance documentation across multiple teams within the Program Office• Developed, designed, and wrote the “Pregnancy Log Feasibility Sub-study” protocol for the NCS• Developed training programs to ensure compliance with Federal and Department of Defense regulations

Responsibilities• Supervised the research department’s daily operations including management and training of research staff• Wrote and maintained site SOPs to ensure site compliance with FDA regulations and Good Clinical Practice • Managed imaging interpretation projects for local oncology research groups conducting clinical trials• Marketed clinical research services to industry sponsors and community researchers• Monitored activity to ensure study enrollment, project goals, quality data and overall compliance• Coordinated industry sponsored and investigator initiated clinical trials within the fields of radiology, nuclear medicine, and oncology diagnostics• Prepared IRB applications to include initial review, amendments, event reporting, and continuing reviewsKey Accomplishments• Contributed to doubling the number clinical research projects conducted resulting in a revenue increase• Successfully developed research budgets and completed contract negotiations• Coordinated protocol development, implementation and manuscript development for various investigator initiated protocols• Contributed to winning the American Society of Clinical Oncology (ASCO) “Outstanding Contribution to Cancer Clinical Trials,” 2007 and the American College of Radiology Imaging Network (ACRIN) “Network Chair’s Institutional Achievement Award,” 2006 and 2007

Responsibilities• Coordinated industry sponsored clinical trials within fields of cardiology, endocrinology, neurology, women’s health and pediatrics• Completion of study site selection visits, site initiation, routine monitoring visits and study close out visits• Conducted research participant recruitment, consent, screening, enrollment, retention and follow up• Completed data collection and sample collection• Assisted with the dispensing, instruction, and reconciliation of investigational medications• Completed the source document information transcription into Case Report Forms/Electronic Data Capture systems, responded to queries, and reported safety events per the protocol and Federal regulations

Responsibilities• Analyzed drinking water, wastewater, hazardous waste, food, air, and miscellaneous samples• Consulted on microbiological and industrial hygiene sampling, including responding to ad hoc inquiries and discussing laboratory results with clients• Completed reports for the Arizona Department of Environmental Quality regarding drinking water analysis