SHAIANE DAVIS
Flourish Research
Sherman,TX
9
years of professional experience
Clinical research professional with experience in clinical research coordination and specialized expertise in source document development. Skilled in interpreting clinical trial protocols and developing accurate, protocol-specific source documentation using Microsoft Word and RealTime eSOURCE. Experienced in source quality control, protocol amendments, clinical documentation, and ICH-GCP/ALCOA-C standards. Detail-oriented and adaptable with a strong understanding of clinical research operations.
Work History
Source Creation Specialist
3 Years- Developed protocol-specific source documents for clinical research studies using Microsoft Word for paper source and RealTime eSOURCE.
- Interpreted study protocols, schedules of assessments, and supporting documents to develop comprehensive source documentation tailored to study design, visit complexity, and protocol requirements.
- Created and maintained source documents throughout the study lifecycle, incorporating protocol amendments, sponsor requests, and study-specific revisions while maintaining accurate version control.
- Performed quality control reviews of source documents to verify accuracy, completeness, protocol alignment, and compliance with ICH-GCP and ALCOA-C principles.
- Managed high-volume source document development across multiple concurrent clinical trials of varying complexity while meeting study-specific timelines and quality standards.
- Applied clinical research coordination experience and medical terminology knowledge to design clear, practical source documentation for site staff conducting participant visits.
Clinical Research Coordinator
2 Years 3 Months- Coordinated patient visits across multiple studies, ensuring adherence to GCP
- Collaborated cross-functionally with clinical, regulatory, quality, and pharmacy teams to support study execution.
- Assisted in verification and preparation of unblinded IP to support study integrity
- Identified workflow gaps and contributed to process improvements supporting site efficiency and study execution.
Clinical Research Coordinator
1 Year- Recruited and scheduled patients for study visits, ensuring optimal participant engagement and compliance with study timelines
- Executed data entry and maintained regulatory documentation with routine quality control to uphold data integrity and compliance standards
- Organized documentation and materials for monitoring visits to ensure compliance and readiness.
Registered Pharmacy Technician
2 Years 4 Months- Assisted pharmacist in preparing labels and filling prescriptions, triaged phone inquiries to enhance workflow
- Responded to and aided in Rapid Responses and ER traumas in a Level I trauma facility
Education
BBS - Communication Sciences and Disorders
Skills
Source Document Development — Microsoft Word & RealTime eSOURCE
Source Document QC/QA
Protocol Interpretation
Protocol Amendment Implementation
ICH-GCP & ALCOA-C
Medical Terminology
Data Integrity & Documentation Review
Clinical Research Operations
Timeline
Source Creation Specialist
Flourish Research
02.2023 - 02.2026Read More
Clinical Research Coordinator
Clinical Trials of Texas
11.2020 - 02.2023Read More
Clinical Research Coordinator
Physicians Research Group
08.2019 - 08.2020Read More
Registered Pharmacy Technician
University Hospital
02.2017 - 06.2019Read More
Hardin-Simmons University
BBS from Communication Sciences and Disorders
Read More