Charlotte tuilevuka
provo
Summary
Experienced in analytical and clinical research management, with comprehensive knowledge of regulatory requirements and clinical trial operations. Strengths include strategic planning, project management, team leadership, and process improvement initiatives to enhance efficiency. Notable contributions include the successful implementation of improvements in clinical trial protocols, resulting in enhanced data accuracy and study performance.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Clinical Research Director
doTERRA
01.2025 - Current
- Facilitating Clinical Studies
- Managed personnel, compliance and regulations, ethical guidelines and leading the team strategically
- Monitored subject enrollment and tracked dropout details.
- Conducted quality assurance reviews of study sites to ensure adherence to Good Clinical Practices.
- Developed training materials for clinical research staff on GCPs, ICH guidelines, and other relevant topics.
- Generated monthly progress reports detailing enrollment numbers, site performance metrics.
- Monitored patient recruitment progress and identified strategies for improvement.
- Educated participants on studies and anticipated outcomes.
- Took vital signs and collected medical histories as part of study protocols.
- Developed and managed clinical research protocols, budgets, and project timelines.
Clinical Research Manager
doTERRA
Pleasant Grove
01.2021 - 12.2024
- Facilitating Clinical Studies
- Assist In planning, organizing research functions
- Support the research staff
- Collaborate with the research staff on SOPs and various documentations associated with clinical research
- Compliant with FDA, HIPAA, GCP, GLP and ICH guidelines and regulations
- Complete requested task independently and as a team
Quality Control Chemistry Supervisor/Chemist III
doTERRA
Pleasant Grove
01.2019 - 12.2020
- Perform physical testing on essential oils using Instrumentation such as FTIR, Refractometer, Polarimeter and Density Meter
- Perform ICPMS and physical testing on supplements, essential oils and personal care
- Perform organoleptic testing of essential oils
- Analyzing essential oils on GCMS and quantitative analysis on GC
- Perform weekly, monthly and preventative maintenance and problem solving on all analytical Instruments
- Perform method validations
- Troubleshoot existing methods and instrumentation
- Write and review SOP's associated with the chemistry lab
- Review testing specifications
- Write and track OOS reports
- Order all supplies needed for chemistry lab and managed inventory
- Review stability results and trends
- Trainer on all methods and SOP's applicable to chemist position
- Helped lab become GMP compliant
- Managed and co-ordinated the workflow, lab safety, waste and calibrations of instrumentation in the chemistry lab
- Communicated and worked with QA, R&D and operations on workflow decisions and discussions
- Managed training paths and goals of all chemistry lab staff
Quality Control Chemist II
doTERRA
Pleasant Grove
10.2015 - 01.2019
- Perform physical testing on essential oils using Instrumentation such as FTIR, Refractometer, Polarimeter and Density Meter
- Perform ICPMS and physical testing on supplements, essential oils and personal care
- Perform organoleptic testing of essential oils
- Analyzing essential oils on GCMS and quantitative analysis on GC
- Perform weekly, monthly and preventative maintenance and problem solving on all analytical instruments
- Perform method validations
- Troubleshoot existing methods and Instrumentation
- Write and review SOP's associated with the chemistry lab
- Review testing specifications
- Write and track OOS reports
- Order supplies needed for chemistry
- Review stability results and trends
- Trainer on all methods and SOP's applicable to chemist position
- Maintained waste and calibrations of instrumentation in the chemistry lab
Quality Control Analytical Chemist
Neways, International
Springville
10.2014 - 10.2015
- Perform potency testing on raw materials, in process samples, and finished products using HPLC, GC, titrations and UV-VIS
- Perform physical testing of products and raw materials, such as FTIR, NiR, pH, viscosity and specific gravity
- Perform weekly, monthly and preventative maintenance and problem solving on all analytical instruments
- Helped with method validations
- Troubleshoot existing methods and instrumentation
- Write and review SOP's associated with the chemistry lab
- Write and track OOS reports
- Order all supplies needed for chemistry lab
Technologist I (Laboratory Scientist)
ARUP Laboratories
Salt Lake City
08.2009 - 10.2014
- Processed data, verified accuracy, and entered data in the laboratory computer system in a timely manner
- Performed internal and external proficiency testing (PT)
- Recognized critical patient results and followed the defined process for reporting them
- Evaluated QC results to determine validity of testing using defined parameters
- Responded to technical questions
- Trained new and current employees in procedures and policies
- Maintained adequate Inventory of reagents and supplies
- Operated, calibrated, and performed minor troubleshooting on laboratory instruments and ensured proper functioning of laboratory equipment
- Performed quality control procedures as specified in lab section SOPs and maintains QC records and documentation
- Ensured samples were tested and reported within the expected turn-around-time
Education
Masters - Pharmaceutical of Science
Roseman University of Health Science
South Jordan, UT05.2024
Bachelor’s - Biochemistry
Brigham Young University of Hawaii
Laie, Hawaii04.2003
Skills
- Data analysis
- Laboratory techniques
- Project management
- Quality assurance
- Effective communication
- Team collaboration
- Study design
- GCP training
- Protocol development
- Site monitoring
- Clinical trial management
- Adverse event reporting
- Clinical data management
- Document management
- Audit preparation
- Clinical monitoring
- Training and mentoring
- Trial management
- Adverse event documentation
- Project planning
References
Available upon request.
Instrument Knowledge
- GC-MS: Agilent 7900 System
- HPLC: Agilent 1100 Series and 1260 Infinity II System, Waters Alliance 2695
- LCMS: Agilent 6100 SQ System 1290 Infinity II flexible pump
- UV-VIS: Agilent 8453
- FTIR: Perkin Elmer Spectrum one and Agilent Cary 630
- NIR: Perkin Elmer Spectrum 1100N
- GC: Agilent 6890N and 7890 series
- GCMS: Agilent 5977 Turbo system
- Polarimeter: Rudolph
- Refractometer: Rudolph
- Density Meter: Rudolph
- Roche 5000 series
- Star LIMS
- Labware
- Millennium
- Mastercontrol
Certification
- Phlebotomist
Timeline
Clinical Research Director
doTERRA
01.2025 - Current
Clinical Research Manager
doTERRA
01.2021 - 12.2024
Quality Control Chemistry Supervisor/Chemist III
doTERRA
01.2019 - 12.2020
Quality Control Chemist II
doTERRA
10.2015 - 01.2019
Quality Control Analytical Chemist
Neways, International
10.2014 - 10.2015
Technologist I (Laboratory Scientist)
ARUP Laboratories
08.2009 - 10.2014
Masters - Pharmaceutical of Science
Roseman University of Health Science
Bachelor’s - Biochemistry
Brigham Young University of Hawaii
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