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 Harmonisation (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.

PROFESSIONAL EXPERIENCE

• 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

ACTIVITIES/AFFILIATIONS/INTEREST

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

AUTHORSHIP

https://about.citiprogram.org/authors/april-smith/