Emily Lute
Leawood,KS
Summary
Knowledgeable Clinical Research Associate with experience in documenting and assisting in clinical trials research. Clear, concise and effective written communication abilities. Thorough knowledge of FDA and GCP principles and regulations. Committed to providing support to the project team and executing responsibilities as instructed.
Overview
4
4
years of professional experience
1
1
Certification
Work History
In-House Clinical Research Associate
Fortrea
07.2023 - Current
- Serve as contact for project team and investigative sites, conduct site contacts, and document contacts for assigned sites
- Monitor site performance and implement action plans for sites
- Assist CRAs with preparation for site visits
- Perform Case Report Form review, query generation, and resolution against established data review guidelines
- Assist with coordination of study visits and shipment of drugs and laboratory supplies
- Manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines
- Demonstrate a thorough understanding of the CTMS
- Assist Project Team in production of Status Reports
- Liaise with Study Start-up and assume maintenance activities after Site Activation
- Assist in submissions to Ethics Committees and Regulatory Authorities.
Research Scientist
Eurofins Viracor Clinical Diagnostics
09.2022 - 07.2023
- Implement research plans, designs, and testing products
- Operate, calibrate, and maintain all laboratory equipment and instruments according to SOPs
- Complete scientific write-ups of results and methods of performed experiments
- Maintain accurate documentation on all research project steps
- Serve as Lead Scientist on development projects for diagnostic assays
- Prepare reagents, standards, controls, proficiency testing material, and patient specimens for analysis and short and long-term storage
- Assist in writing validation reports, SOPs, and study-specific work instructions
- Participate in quality assurance/quality improvement activities.
Laboratory Analyst
ICON
10.2021 - 08.2022
- Perform routine sample analysis via PK and ADA ELISA assays
- Interpret data, process/report results, and approve or reject sample analysis
- Train new analysts in accordance with SOPs and standard GxP regulations
- Serve as Lead Analyst on selected studies
- Assist with study method validation
- Inform clients of assay problems and inconsistencies
- Identify deviations from SOPs and perform investigations
- Perform data review for quality control
- Thoroughly understand and comply with GxP regulations
- Ensure on-time task completion to support overall goal of on-time study completion
- Verify and calibrate equipment as needed.
Laboratory Associate
ICON
03.2021 - 10.2021
- Assist in study setup for collection, storage, and processing of samples
- Process biological samples from clinic
- Report results of biological samples
- Pipette and aliquot biological samples for assays
- Prepare the documentation of sample storage while following processing instructions
- Stock/order materials and reagents for the clinical laboratory.
Laboratory Data Entry Quality Control Reviewer
Eurofins Viracor Clinical Diagnostics
06.2020 - 03.2021
- Review interface and manual test orders to ensure accuracy
- Utilize laboratory information systems to access patient information
- Maintain detailed and accurate records
- Complete correction requests in a timely manner.
Education
Master of Science - Microbiology
University of Florida
Bachelor of Science - Biology
University of Central Missouri
Skills
- Remote monitoring
- Site management
- Clinical documentation
- Regulatory compliance
- Experimental design
- Data analysis
- Quality assurance
- Good Clinical Practice
- Pharmacovigilance
- Report writing
- Research and Development
- Documentation requirements
- Informed consent
- Teamwork and collaboration
- Time management
- Task prioritization
Certification
- Advanced International Pharmacovigilance and Argus Safety, Certified Clinical Research Professionals Society, 05/2023
- Lean Six Sigma Yellow Belt, Lean Six Sigma, 12/2022
Database Experience
- Argus
- Clinicaltrials.gov
- CTMS
- Medidata
- Florence
- Veeva Vault
- PubMed
- NCBI
Timeline
In-House Clinical Research Associate
Fortrea
07.2023 - Current
Research Scientist
Eurofins Viracor Clinical Diagnostics
09.2022 - 07.2023
Laboratory Analyst
ICON
10.2021 - 08.2022
Laboratory Associate
ICON
03.2021 - 10.2021
Laboratory Data Entry Quality Control Reviewer
Eurofins Viracor Clinical Diagnostics
06.2020 - 03.2021
Master of Science - Microbiology
University of Florida
Bachelor of Science - Biology
University of Central Missouri
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