Brittany Holloway, MSN, RN
Pearland,TX
Summary
Dedicated Senior Clinical Research Associate successful at evaluating sites, initiating trials and managing closeouts. Experienced with trials and successful at adapting to new processes. Bringing excellent organizational, planning and interpersonal skills gained during several-year career.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Senior Clinical Research Associate
Advanced Clinical
Dallas, TX
01.2020 - 10.2023
- Conducts site management activities including site selection visits, site initiation visits, site training, site interim monitoring visits, and site close out visits.
- Ensure the conduct of all clinical studies is in accordance with Good Clinical Practices, International Harmonization Guideline, and appropriate Standard Operating Procedures (SOP).
- Serve as primary contact for CROs/vendors, Investigators, and Study Coordinators for study related questions.
- Support feasibility and site selection process for clinical studies.
- Facilitate and support development and review of clinical protocols, informed consent forms, or other study-related clinical documents.
- Manage patient recruitment strategies to increase patient randomization into the trial.
- Review all AE/SAEs and ensure appropriate documentation is in place and any other safety issues are addressed and communicated.
- Assist and support data validation and data cleaning procedures to ensure timelines are met.
- Develop and maintain tracking tools to support management of clinical studies.
Clinical Research Associate I
Syneos Health
Dallas, TX
06.2018 - 12.2019
- Performed site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and protocol compliance.
- Assessed site processes.
- Conducted Source Document Review of appropriate site source documents and medical records.
- Verified required clinical data entered in the case report form (CRF) is accurate and complete.
- Applied query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
- Performed investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol.
- Routinely reviewed the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF).
- Acted as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.
- Attended sponsor meetings as necessary.
Patient Care Technician
First Choice Emergency Room
Houston , TX
02.2010 - 01.2016
- Obtained patient vital signs and reported results to staff nurse or physician to identify changes from prior measurements.
- Collected biological specimens and packaged for laboratory transport to complete diagnostic tests.
- Responded to bell or light signal calls to assist patients with needs.
- Performed variety of delegated basic patient care services to support nursing functions and activities of daily living.
- Documented patient intake and dietary requirements and aided with feeding and monitoring.
- Delivered outstanding patient care based on physical, psychological, educational and related criteria.
- Identified and reported observations and clinical symptoms to appropriate healthcare professionals, driving timely intervention.
- Supported healthy patient skin with bedside baths, wound care and integrity checks.
- Prepared patient chart for admission and compiled appropriate paperwork.
Clinical Research Assistant
North Cypress Medical Center
Cypress, TX
01.2009 - 02.2010
- Identified potential subjects through outreach efforts at local clinics or physician offices utilizing approved recruitment materials.
- Analyzed data collected from various sources such as laboratory results or patient questionnaires for quality assurance purposes.
- Assisted in the preparation of study protocols and informed consent documents for clinical trials.
- Monitored compliance with Good Clinical Practices, International Council on Harmonization guidelines, and applicable regulations.
- Collected, processed and delivered specimens from trial participants.
Education
Master of Science - Nursing
Texas Woman's University
Denton, Texas08-2024
Bachelor of Science - Nursing
The University of Texas Health Science Center
Houston, Texas12.2016
Skills
- Research and Development
- Site Management
- Patient recruitment strategies
- Good clinical practice
- Clinical Documentation
- Interactive management
- Reviewing data standards
- Patient Safety
Certification
- Licensed Registered Nurse - 932507
- Basic Life Support (BLS) Certification
- Advanced Cardiac Life Support Certification
Timeline
Senior Clinical Research Associate
Advanced Clinical
01.2020 - 10.2023
Clinical Research Associate I
Syneos Health
06.2018 - 12.2019
Patient Care Technician
First Choice Emergency Room
02.2010 - 01.2016
Clinical Research Assistant
North Cypress Medical Center
01.2009 - 02.2010
Master of Science - Nursing
Texas Woman's University
Bachelor of Science - Nursing
The University of Texas Health Science Center
- Licensed Registered Nurse - 932507
- Basic Life Support (BLS) Certification
- Advanced Cardiac Life Support Certification
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