Shawn Smitherman
Oklahoma City,OK
Summary
Dedicated Senior Clinical Research Associate II with more than 22 years of experience in healthcare and research. A proven track record, adept in quality assurance techniques and team leadership. Expert in managing clinical trials, ensuring adherence to ICH-GCP guidelines, and leveraging biostatistics for data analysis. Demonstrated ability to enhance team performance and project outcomes through analytical thinking and excellent communication.
Thorough background in overseeing clinical trials from initiation to close-out. Proven record in ensuring protocol compliance and managing site performance.
Vast knowledge of analyzing data for Clinical Outcomes. Experience working with prediction models. Broad background in clinical trials management of phase I/II/III/IV trials in various therapeutic areas such as Cardiology, Dermatology, Oncology, Neurology, Pulmonology, Endocrinology, Nephrology, and Ophthalmology.
Overview
22
22
years of professional experience
Work History
Senior Clinical Research Associate II
SyneosHealth
09.2024 - Current
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Communicated project status to management verbally and through technical documentation and presentations.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Managed project risk by identifying, quantifying and monitoring potential threats.
- Complied with research protocols by providing ongoing quality control audits.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Ensured timely completion of monitoring visits, enabling consistent oversight of site performance and adherence to Good Clinical Practice guidelines.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Oversee and manage quality events/deviations including root cause analysis, CAPA development and implementation, effectiveness check tracking, and non-compliance reporting GCP and applicable regulatory requirements
- Developed solutions by researching advanced technologies, methods for modeling and predicting performance outcomes and innovative approaches for personalized and adaptive user support.
Senior Clinical Research Associate
Parexel
10.2013 - 08.2024
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Communicated project status to management verbally and through technical documentation and presentations.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Managed project risk by identifying, quantifying and monitoring potential threats.
- Complied with research protocols by providing ongoing quality control audits.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Ensured timely completion of monitoring visits, enabling consistent oversight of site performance and adherence to Good Clinical Practice guidelines.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Oversee and manage quality events/deviations including root cause analysis, CAPA development and implementation, effectiveness check tracking, and non compliance reporting GCP and applicable regulatory requirements
- Developed solutions by researching advanced technologies, methods for modeling and predicting performance outcomes and innovative approaches for personalized and adaptive user support.
Senior Clinical Research Associate
Midwest Center for Clinical Research
05.2012 - 06.2013
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Communicated project status to management verbally and through technical documentation and presentations.
- Collaborated with biostatistics team members on data analysis plans, ensuring accurate interpretation and reporting of study results.
- Ensured timely completion of monitoring visits, enabling consistent oversight of site performance and adherence to Good Clinical Practice guidelines.
Clinical Research Associate
St Luke’s Heart Hospital
04.2008 - 06.2011
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Observed clinical studies and assessed health outcomes in groups of participants to support research plan.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Collected, evaluated, and modeled collected data.
- Obtain statistical components of protocols pertaining to development-phase projects. Analyze and prepare charts, graphs and manuscripts for publication. Apply statistical theory to collect, organize, and analyze data. Analyze data and apply different statistical techniques such as: regression, analysis of variance.
Aerospace Medicine Nurse
US Air Force
02.2003 - 02.2007
- Performed accurate documentation of patient assessments, interventions, and outcomes in compliance with regulatory standards.
- Administered medications via oral, IV, and intramuscular injections and monitored responses.
- Performed routine wound care and dressing changes on schedule.
- Promoted a safe and comfortable healing environment by addressing patient concerns promptly and professionally.
- Neonatal Care, Women’s health, Labor and Delivery, Family Practice, and Emergency Room care. Assisted in delivery of newborns as a Labor and Delivery Nurse Evaluated, administered medication, and monitored life support of patients in Neonatal Intensive Care Unit.
Education
Associate of Applied Science - Nursing
Community College of United States Air Force
Offutt AFB06-2006
Bachelor of Science - Sociology
University of Oklahoma
Norman, OK05-2001
Skills
- Quality assurance techniques
- Team leadership qualities
- Clinical trial management
- Therapeutic area expertise
- Biostatistics
- ICH-GCP guidelines
- Data analysis
- Teamwork
- Analytical thinking
- Excellent communication
Languages
Spanish
Elementary
Timeline
Senior Clinical Research Associate II
SyneosHealth
09.2024 - Current
Senior Clinical Research Associate
Parexel
10.2013 - 08.2024
Senior Clinical Research Associate
Midwest Center for Clinical Research
05.2012 - 06.2013
Clinical Research Associate
St Luke’s Heart Hospital
04.2008 - 06.2011
Aerospace Medicine Nurse
US Air Force
02.2003 - 02.2007
Associate of Applied Science - Nursing
Community College of United States Air Force
Bachelor of Science - Sociology
University of Oklahoma
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