Clinical Research Quality Control

Dawn Walker

Raleigh, NC *****

919-***-**** ************@*****.*** http://www.linkedin.com/in/dawn-walker

CLINICAL RESEARCH ASSOCIATE

Expertise in executing clinical research projects, proficient in data collection and analysis. Demonstrated ability to recruit diverse study participants and manage laboratory operations efficiently. Strong understanding of quality control measures, process streamlining, and clinical research processes.

SKILLS & PROFICIENCIES

GCP Regulations Process Improvement Clinical Monitoring Clinical Development Serious Adverse Event Reporting SOPs Conflict Management and Resolution Healthcare Administration Medical Record Data Management Case Report Forms HIPAA

PROFESSIONAL EXPERIENCE

PAREXEL INTERNATIONAL, Raleigh, NC August 2024 – Current

Research organization, providing research, management and analysis of programs to support clinical development

Site Monitor I

Ensured data integrity at the site level by upholding the International Council for Harmonization and Good Clinical Practices (ICH GCPs), local requirements, relevant regulations and all applicable Standard Operating Procedures (SOPs) and processes.

Conducted site-level monitoring activities in line with Study Monitoring Plan (SMP), to include but not limited to: Informed consent review in accordance with the SMP requirements, Reviewed/verified source and data in accordance with SMP requirements, Verified Investigational Product (IP) inventory, preparation, dispensation/administration according to protocol, Investigator’s Brochure (IB), Investigational Product (IP) Manual, Dosage Administration Instructions (DAI) and Investigational Medicinal Product (IMP) label, Managed reporting of protocol deviations and appropriate follow up, Applied query resolution techniques remotely and onsite driving to closure within agreed timelines, Managed issue and action items to ensure appropriate resolution within agreed timelines.

ICON PLC, Raleigh, NC May 2022 – May 2024

Research organization, providing research, management and analysis of programs to support clinical development

Clinical Research Associate I

Contributed to successful execution of clinical research projects through monitoring study protocols, analyzing data, maintaining documentation and implementation of SOPs. Participated in study team meetings and provided valuable insights and recommendations.

Conducted thorough monitoring and site visits to ensure compliance with study protocols and regulatory requirements.

Collected and analyzed data, ensuring accuracy and completeness for further analysis.

Collaborated with cross-functional teams for timely and accurate reporting of study progress and findings.

Assisted in implementation of study protocols and standard operating procedures for streamlined clinical site use

Maintained meticulous documentation and records, ensuring data integrity and traceability.

Demonstrated strong attention to detail and adherence to ethical guidelines throughout the research process.

WAKE RESEARCH, Raleigh, NC April 2021 – May 2022

Clinical research organization meeting the needs of biopharmaceutical industry

Clinical Research Coordinator

Coordinated all aspects of clinical research studies, including identifying participants, performing study visits, preparing documentation, and collaborating with investigators to analyze and interpret data.

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.

Participated in meetings, Site Initiation Visits (SIVs), and events, fostering effective communication and collaboration within research team.

Maintained accurate and up-to-date data entry, ensuring consistency and reliability of study data for analysis and reporting.

Collaborated closely with investigators to analyze and interpret clinical study procedures and results, contributing to the preparation of presentations, reports, and conclusions.

Prepared comprehensive and well-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.

Dawn Walker 919-***-**** ************@*****.*** Page 2

Medical Technologist/Lead Technologist September 2018 – October 2020

Local Public Health Organization meeting the healthcare needs of community.

Managed daily laboratory operations, overseeing specimen analysis, quality control management, phlebotomy, result reporting, patient flow coordination, clinical inventory, and specimen processing.

Collaborated with cross-functional teams to troubleshoot and resolve technical issues, minimizing downtime and ensuring uninterrupted laboratory operations.

Developed and implemented streamlined processes for specimen handling and processing, reducing turnaround time by 20% and improving overall efficiency.

Prioritized patient safety and confidentiality, adhering to HIPAA regulations and maintaining strict data security protocols.

Coordinated proficiency testing activities, consistently achieving high scores, and demonstrating proficiency in laboratory techniques and procedures.

Implemented and maintained rigorous quality control measures, ensuring accurate and reliable test results and adherence to regulatory standards.

Proofread all reports and documentation, ensuring accuracy and completeness of information.

BLUE RIDGE FAMILY PHYSICIANS, Raleigh, NC April 2014 – September 2018

Family practice, treating adults and children

Laboratory Manager

Oversaw and managed daily laboratory operations, including specimen analysis, quality control, proficiency testing, phlebotomy, specimen processing, patient flow coordination, result reporting, specimen turnaround times, and reference laboratory specimen management.

Streamlined laboratory processes, resulting in a 20% reduction in turnaround times and improved efficiency.

Implemented and maintained rigorous quality control measures, ensuring accurate and reliable test results and adherence to regulatory standards.

Developed and implemented training programs for laboratory staff, ensuring proficiency in laboratory techniques and protocols.

Coordinated with healthcare providers and staff to ensure timely and accurate reporting of test results, facilitating effective patient care.

Conducted regular audits and inspections to identify areas for improvement and implement corrective actions.

WAKEMED HEALTH AND HOSPITALS, Raleigh, NC July 2011 – April 2014

Hospital part of 919-bed healthcare system with multiple facilities

Medical Laboratory Technician

REX HOSPITAL, Raleigh, NC September 2000 – July 2014

General hospital

Medical Laboratory Technician

EDUCATION

Bachelor of Science, Healthcare Administration, Axia, Phoenix, AZ

PROFESSIONAL DEVELOPMENT & CERTIFICATIONS

Surgical Technology, Miller Motte Community College, Medical Laboratory Technology, WakeTech Community College

Clinical Medical Assistant, Intramed Institute

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