Dawn Walker
Raleigh
Summary
Dynamic Clinical Research Associate II with proven expertise at Avance Clinical in ensuring regulatory compliance and data integrity. Skilled in GCP regulations and conflict resolution, I successfully enhance trial efficiency and accuracy, contributing to streamlined processes and improved patient safety. Adept at collaborating with cross-functional teams to resolve study-related challenges.
Overview
26
26
years of professional experience
Work History
Clinical Research Associate II
Avance Clinical
Wake Forest
07.2025 - Current
- Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
- Monitored safety events reported during the course of clinical trials in accordance with SOPs.
- Reviewed case report forms to ensure accuracy and completeness for regulatory compliance.
- Conducted site visits to assess trial progress and support staff.
- Performed pre-study site evaluations, site initiations, interim monitoring and study close-out visits while collecting regulatory documentation.
- Documented findings and maintained accurate trial records for audits.
- Analyzed collected data for accuracy prior to database lock; identified discrepancies when necessary.
- Collaborated with cross-functional teams to address study-related issues.
- Engaged with sponsors, CROs, investigators, vendors, and subcontractors to enhance communication and resolve study-related issues.
- Trained site personnel on study protocols and procedures.
- Provided training on GCP standards to new personnel or existing staff members.
- Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
- Ensured timely completion of all deliverables by tracking project timelines and milestones.
Site Monitor I
PAREXEL INTERNATIONAL
Raleigh
08.2024 - 05.2025
- Executed site-level monitoring activities per Study Monitoring Plan (SMP), including informed consent review, source and data verification, and Investigational Product (IP) verification.
- Maintained data integrity at site level by upholding ICH GCPs, local requirements, relevant regulations, and applicable SOPs.
- Research organization, providing research, management and analysis of programs to support clinical development
Clinical Research Associate I
ICON plc
Raleigh
05.2022 - 05.2024
- Conducted thorough monitoring and site visits to ensure compliance with study protocols and regulatory requirements.
- Facilitated execution of clinical research projects by monitoring study protocols, analyzing data, maintaining documentation, and implementing SOPs; participated in study team meetings to provide insights and recommendations.
- Assisted in implementation of study protocols and standard operating procedures for streamlined clinical site use.
- Coordinated with cross-functional teams to ensure timely and accurate reporting of study progress and findings.
- Maintained meticulous documentation and records to uphold data integrity and traceability.
- Collected and analyzed data, ensuring accuracy and completeness for further analysis.
- Demonstrated strong attention to detail and adherence to ethical guidelines throughout the research process.
- Research organization, providing research, management and analysis of programs to support clinical development
Clinical Research Coordinator
Wake Research
Raleigh
04.2021 - 05.2022
- Recruited and screened a diverse and representative sample of potential study participants, adhering to strict ethical guidelines and regulatory requirements, ensuring the validity and generalizability of clinical research studies.
- Coordinated all aspects of clinical research studies, including identifying participants, performing study visits, preparing documentation, and collaborating with investigators to analyze and interpret data.
- Collaborated closely with investigators to analyze and interpret clinical study procedures and results, contributing to the preparation of presentations, reports, and conclusions.
- Facilitated meetings, Site Initiation Visits (SIVs), and events to enhance communication and collaboration within research team.
- Ensured accurate and timely data entry, supporting consistency and reliability of study data for analysis and reporting.
- Created and organized study-related documentation, including progress notes, adverse event reports, Institutional Review Board documents, and participant instructional guides.
- Ensured clarity and comprehensibility in all documentation and communication, avoiding technical jargon and using plain language to facilitate understanding by all stakeholders.
- Facilitated clinical research organization to address specific needs of biopharmaceutical industry.
Medical Technologist/Lead Technologist
Local Public Health Organization
09.2018 - 10.2020
- Managed daily laboratory operations, overseeing specimen analysis, quality control, phlebotomy, result reporting, patient flow coordination, clinical inventory, and specimen processing to ensure timely and accurate results.
- Implemented and maintained rigorous quality control measures, ensuring accurate and reliable test results and adherence to regulatory standards.
- Developed and implemented streamlined processes for specimen handling and processing, reducing turnaround time by 20% and improving overall efficiency.
- Collaborated with cross-functional teams to troubleshoot and resolve technical issues, minimizing downtime and supporting continuous laboratory operations.
- Coordinated proficiency testing activities, consistently achieving high scores to validate expertise in laboratory techniques and procedures.
- Prioritized patient safety and confidentiality, adhering to HIPAA regulations and maintaining strict data security protocols.
- Proofread all reports and documentation, ensuring accuracy and completeness of information.
- Facilitated access to healthcare resources for local residents.
Laboratory Manager
Blue Ridge Family Physicians
Raleigh
04.2014 - 09.2018
- Managed daily laboratory operations, ensuring efficient specimen analysis, quality control, proficiency testing, phlebotomy, specimen processing, patient flow coordination, result reporting, and reference laboratory specimen management.
- Implemented and maintained rigorous quality control measures, ensuring accurate and reliable test results and adherence to regulatory standards.
- Streamlined laboratory processes, resulting in a 20% reduction in turnaround times and improved efficiency.
- Developed and implemented training programs for laboratory staff, ensuring proficiency in laboratory techniques and protocols.
- Collaborated with healthcare providers and staff to ensure timely, accurate reporting of test results, enhancing patient care.
- Performed regular audits and inspections to identify improvement areas and implement corrective actions.
- Provided comprehensive family practice services to adults and children in a clinical setting.
Medical Laboratory Technician
Rex Hospital
Raleigh
09.2000 - 07.2014
- Conducted routine laboratory tests on patient samples for accurate diagnostics.
- Operated and maintained laboratory equipment to ensure proper functionality.
- Prepared specimens for analysis, including labeling and storage procedures.
- Provided patient care in general hospital, supporting and assisting during treatment
Medical Laboratory Technician
WakeMed Health and Hospitals
Raleigh
07.2011 - 04.2014
- Conducted routine laboratory tests on various biological samples.
- Operated and maintained laboratory equipment for accurate results.
- Collaborated with healthcare professionals to discuss test findings.
- Supported laboratory operations within a 919-bed healthcare system across multiple facilities.
Education
Bachelor of Science - Healthcare Administration
Axia College
Raleigh, NC07-2012
Skills
- Clinical Monitoring
- Clinical Development
- Adverse event reporting
- GCP compliance
- Regulatory compliance
- Standard operating procedures
- Data Management
- Case Report Forms
- Quality control
- Process Improvement
- Problem solving
- HIPAA
Professional Development And Certifications
- Surgical Technology, Miller Motte Community College
- Medical Laboratory Technology, WakeTech Community College
- Clinical Medical Assistant, Intramed Institute
Timeline
Clinical Research Associate II
Avance Clinical
07.2025 - Current
Site Monitor I
PAREXEL INTERNATIONAL
08.2024 - 05.2025
Clinical Research Associate I
ICON plc
05.2022 - 05.2024
Clinical Research Coordinator
Wake Research
04.2021 - 05.2022
Medical Technologist/Lead Technologist
Local Public Health Organization
09.2018 - 10.2020
Laboratory Manager
Blue Ridge Family Physicians
04.2014 - 09.2018
Medical Laboratory Technician
WakeMed Health and Hospitals
07.2011 - 04.2014
Medical Laboratory Technician
Rex Hospital
09.2000 - 07.2014
Bachelor of Science - Healthcare Administration
Axia College