April L. Smith, BA, CIP, CCRP

2214 Burningwood Lane, Lee’s Summit, MO 64082

W. 518.601.5810 C. 216.659.2555 smitha@thehrpconsutinggroup.com

https://www.regulatory7.com/mission

QUALIFICATIONS

~ Human Subjects Research Protection ~ Compliance ~ Regulatory Support

Dedicated professional with 17 years’ experience in the oversight of all human subject research. Extensive knowledge of the operational functions of Clinical Research as it relates to the Institutional Review Board (IRB), Regulatory Specialist, Data Management including understanding of Good Clinical Practice (GCP) and a Comprehensive knowledge of Standard Operating Procedures (SOP’s). Assurance that the institution adheres to the guidelines of the Office of Human Research Protection (OHRP), National Institute of Health (NIH, the Food and Drug Administration (FDA), the International Council of Hamonisation (ICH) and many other Regulatory Bodies.

Strong expertise in building relationships with internal stakeholders, including consulting with researchers and members of the protocol management team. Retain and develop quality committee managers who oversee the Research Protocol Analysts. Liaise with research compliance and internal audit representatives as appropriate. Works with various stakeholders to build consensus and navigate the research culture to effect change.

ACADEMIC EXPERIENCE

Cleveland State University Cleveland, OH

Bachelor of Arts, December 2005

Major: Communications | Focus, Marketing/Advertising/Public Relations

PROFESSIONAL EXPERIENCE

The HRP Consulting Group Remote

Consultant 11/2022 – Present

Provide human research protections and other research ethics and compliance consulting services as requested by the Company and agreed upon by the Consultant such as.

• General Consulting

• Program Evaluation

• Program Enhancement

• Process Evaluation / Process Mapping

• Accreditation Assistance

• Customize Policies, Procedures, & Tools

• Committee Start-up & Support

• Research Administration / Operations

• Training & Education

• Compliance Assessments, Audits

• IRB Reliance

• Interactions with Federal Agencies

Saint Luke’s Health System (SLHS) Kansas City, MO

Institutional Review Board Manager, 08/2017 – 12/2022

• Work directly with the Chief Executive Officer (CEO) to ensure the rights and welfare of SLH’s research participants are protected while ensuring quality review of human subjects’ research though SLH’s IRB.

• Operational oversight and management of the IRB to ensure full compliance with Institutional, State and Federal Regulations and guidance regarding human subjects’ protection as per the Common Rule (45 CFR 46), the Privacy Rule (45 CFR 160, 164), and the FDA (21 CFR 50, 21 CFR 56), and others as needed.

• Development of Institutional Review Boards (IRBs)

• Develop and maintain HRP infrastructure: policies, procedures, and guidance and Federalwide Assurance (“FWA”).

• Establish and manage IRB reliance and Central IRB agreements.

• Hire and manage staff as well as educational opportunities.

• Collaborate directly with senior leadership such as the IRB Chair (s) and Vice Chair (s), as well as the leadership of associated research functions: Operations, Finance, and Sponsored Projects.

• Develop and defend the distribution and accounting of department budget.

• Launching a new IRB Compliance electronic system iMedRIS

• Provide continuing education on Human Subjects Research

University Hospitals Cleveland Medical Center Cleveland, OH

Institutional Review Board Manager, 9/2016 – 07/17

Clinical Research Center (CRC)

Provide leadership and administrative oversight for all operations supporting the Committee on Clinical Investigations, the Institutional Review Board for the institution. Manage administrative staff of twelve employees, including administrators, protocol coordinators, liaison/auditors, and intake staff.

Serve as Committee member and Executive Committee member. Provide operational interface between the Committee Chair, Administrative Staff, Research and Academic Affairs, legal and compliance, and the Clinical Research Community.

Serve as regulatory/ethical resource for Committee members. Staff and researchers. Provide oversight of internal for-cause, and not-for-cause audits. Develop and implement policies and procedures related to administrative operations in compliance with applicable federal and state regulations, and institutional policies related to human subject research.

Senior IRB Analyst 01/2011 – 07/17

Clinical Research Center (CRC)

• Develop, implement, and manage efficient procedures to facilitate the processing of human research protocols in accordance with Standard, federal, accreditation, and state policies and procedures.

• Perform review of complex research protocols, including identifying problems and issues in the submission application and contacting the investigator orally or in writing to request additional materials.

• Plan and coordinate monthly IRB review and follow-up activities.

• Serve as an expert liaison between the research investigator and the reviewer; educate parties on relevant and emerging regulations and related risk management issues.

• Apply knowledge of federal, state, and local regulations, as well as healthcare policies and practices, to ensure satisfactory of research compliance.

• Aid management in preparation for accreditation and in various compliance and quality assurance activities.

• Maintains office research files that are of a confidential nature and subject to audit by regulatory agencies.

• Prepare IRB regulatory submission applications, initiate and manage study regulatory files for all research projects. Assist in the preparation of research plans, consent forms, recruitment scripts, and other study materials, as needed.

• Track protocols through the IRB/committee approval process, evaluates for recurrent problems, develops, and implements systems to decrease delays in the project approval process and intervenes as required to facilitate approval.

• Review, edit and enhance study protocols to meet IRB regulations. Evaluate submissions for recurrent problems, develop and implement systems to decrease delays in the project approval process and intervene as required to facilitate approval.

• Oversee submission of amendments, yearly protocol renewals and study protocol terminations. Remain up to date on IRB revisions and modifications to procedures and templates and make sure that these are implemented accordingly across research projects.

• Attend relevant conferences and meetings to stay abreast of current information on the ethics and legal issues related to human subject protections, as well as best practices.

• Assist the faculty and staff of the Research Division with administrative procedures related to the hiring of student interns, track attendance, oversee management of the Research library, and other administrative and organizations tasks as needed.

Cleveland Clinic Taussig Cancer Institute Cleveland, OH

Research Coordinator II 04/2007- 10/2011

• Under the general supervision of the Division Administrator and the Division Chairman, provides direct support and coordinates administrative activities for the Division.

• Prepare, submit, and maintain clinical trials.

• Maintain regulatory documentation, complete CRF’s and medical source records

• Maintain compliance with the FDA, NIH, GCP and ICH

• Report and Adhere to the IRB

• Involved in Protocol Development

• Reports, monitors, distribute and maintain files for all safety information including Investigational Drug Brochures, IND safety reports and Serious Adverse Events (SAE) reports.

• Ensuring that previous, existing, and future protocols are maintained, accurately transferred and followed.

• Maintaining the highest level of quality and assurance and stay in accordance with the local and central Institutional Review Boards.

• Maintain regularity and source documentation for Quality Assurance internal affairs as well as Corporate Compliance

• Act as a clinical resource to team members, clinical staff, various pharmaceutical and other companies.

• Conduct and coordinate Site Initiation Visits, monitoring visit and various other study start-up activities.

• Start-up, complete, implement, revised, and negotiate study budgets.

• Extensive research and gathering data for clinical research and development. Entering gathered data into comprehensive database for physician and intuitional use for accredited use and medical research.

• Create, design, format, and write for the department newsletter letter.

• Administrative duties such as preparing email, faxes, and transmittal letters, etc.

ACTIVITIES/AFFILIATIONS/INTEREST

Former Saint Luke’s Health System (SLHS) IRB Member, Member of the UH Clinical Research Community Advisory Board, Member of the Society of Clinical Research Associates (SOCRA), Public Responsibility in Medicine and Research (PRIM&R) member, Research Acceleration, and Improvement Network (RAIN) Subcommittee IRB Partnership, The American Heart Association (AMA), Leukemia & Lymphoma Society (LLS), Suburban Balance and Jack and Jill of Kansas City.

CURRICULUM DEVELOPMENT / LECTURES

• Guest Lecture, Kansas University Medical Center (KUMC) - Clinical Trials on Study Monitoring

• PRIM&R Presenter – Best Practices for Communicating QA/QI Findings to External Groups

• Other Presentations: IRB Survival Guide, Reliant Review, Quality Improvement versus Research and how it relates to the Common Rule

PUBLICATIONS/PAPERS

• 607 Final Results from the Phase II Continuation Study of the Lenalidomide and Azacitidine Combination in Patients with Higher-Rick Myelodysplastic Syndromes (MDS); Oral Abstract 53rd ASH Conference

• 1496 Outcomes in Obese and Overweight Acute Myeloid Leukemia (AML) Patients Receiving Chemotherapy Dosed According to Actual Body Weight; Oral and Poster Abstract 53rd ASH Conference