DONNA BREAZEALE
FLORENCE,MS
Summary
Highly-motivated professional with desire to take on new challenges. Strong work ethic, adaptability and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.
Overview
20
20
years of professional experience
Work History
REGULATORY AFFAIRS SPECIALIST
University of Mississippi Medical Center
Jackson, MS
01.2018 - 12.2023
- Managed the Cancer Center’s Clinical Cancer Committee, ensuring institutional compliance with the current version of accreditation standards.
- Worked with disease-site programs and clinicians to manage, track and report on cancer program services.
- Managed schedules and agendas of the Clinical Cancer Committee to ensure compliance with COC standards and recorded detailed meeting minutes.
- Prepared required reports on quality projects and program services; created data collection tools to ensure all elements of required reporting are obtained, documented and presented to the Clinical Cancer Committee.
- Facilitated team meetings and collaborated with project teams to ensure timely planning, organization, and execution of quality improvement initiatives.
- Performed data analysis to quantify performance and project results.
- Acted as the primary regulatory representative at internal meetings as well as meetings with Commission on Cancer (COC) personnel.
- Organized cancer program accreditation visits and prepared supporting documentation with accrediting agencies, UMMC staff and officials.
- Contributed to the development of cancer program policies and procedures, facilitated annual review of policies and procedures, and uploaded documents into UMMC's policy tracking center.
MANAGER, CLINICAL RESEARCH
University of Mississippi Medical Center
Jackson, MS
11.2016 - 01.2018
- Managed and guided the daily operations of the clinical research staff.
- Prepared and administered staff performance evaluations.
- Continuously monitored work flow to identify improvement opportunities.
- Oversaw financial aspects of multiple clinical research projects.
- Assisted in finalizing study budgets and agreements with pre-award staff.
- Supervised clinical research staff for timely submission of regulatory items and high-quality data standards.
- Collaborated with study investigators and clinical research staff to enhance study enrollment.
- Prepared and implemented departmental policies and procedures.
- Assisted in completing regulatory documentation for current and new research studies.
DATA QUALITY ANALYST
University of Mississippi Medical Center
Jackson, MS
01.2016 - 11.2016
- Assessed electronic health records of bone marrow transplant patients to evaluate treatment effectiveness and patient progress.
- Timely and accurate data entry into the bone marrow transplant registry.
- Reported case load expectation and completion to the transplant team.
- Developed and maintained work tools to assist in completion of data submissions.
CLINICAL TRIALS COORDINATOR
University of Mississippi Medical Center
Jackson, MS
01.2011 - 01.2016
- Managed research regulatory; prepared clinical trial applications and consent documents for new, revised, and continuing research.
- Maintained complete and accurate research records.
- Created and maintained electronic data tools for improved function of the department.
- Assisted with development and implementation of department policies and procedures.
- Screened and enrolled eligible patients to clinical trials.
- Worked with investigators and study staff to ensure protocol adherence.
- Submitted accurate and timely research data to the sponsor.
- Coordinated sponsor site visits and participated in monitoring/audit visits.
- Prepared and submitted regulatory documents for research investigators.
- Maintained up-to date knowledge of institutional guidelines and federal regulations related to research.
PERFORMANCE IMPROVEMENT COORDINATOR
University of Mississippi Medical Center
Jackson, MS
08.2009 - 01.2011
- Reviewed and abstracted data from medical records for core components related to an assigned patient diagnosis.
- Worked with assigned units to create and perform annual quality improvement initiatives.
- Initiated and participated in collaborative performance improvement projects.
- Reviewed, investigated and reported findings on identified risk occurrences.
- Worked with hospital teams to develop physician order sets utilized to ensure high standards of care.
COMPLIANCE ANALYST
University of Mississippi Medical Center
Jackson, MS
09.2003 - 08.2009
- Developed and implemented the institutional audit plan for clinical research.
- Created functional audit and data tools.
- Conducted routine compliance audits for clinical research throughout the organization, ensuring adherence to standards in investigator record keeping, IRB approvals, and patient consent.
- Conducted audits of pharmacy records to ensure proper storage and documentation of investigational drugs.
- Conducted audits of controlled substances used in research to ensure adequate DEA licensure, and accurate drug logs, on-hand inventory, and storage.
- Compiled statistics and reported audit findings to the Research Compliance Committee.
- Provided education on federal regulations and institutional policies related to research to investigators and leadership.
- Assisted investigators and research staff with corrective measures to facilitate compliance.
- Audited the Institutional Review Board for record maintenance and review processes to ensure concordance with federal regulations.
- Audited patient accounts for accurate research billing; prepared and presented research billing reports to oversight committee.
Education
BACHELORS IN HEALTH INFORMATICS AND INFORMATION -
University of Mississippi Medical Center
05-2013
ASSOCIATES IN HEALTH INFORMATION TECHNOLOGY -
Hinds Community College
05-1995
Skills
- Audits
- Regulatory Submissions
- Project Management
- Data Collection
- Good clinical practice
- Written Communication
- Reliability
- Multitasking
- Professional Demeanor
- Decision-Making
- Adaptability
- Problem-Solving
- Team Collaboration
- Analytical Skills
Timeline
REGULATORY AFFAIRS SPECIALIST
University of Mississippi Medical Center
01.2018 - 12.2023
MANAGER, CLINICAL RESEARCH
University of Mississippi Medical Center
11.2016 - 01.2018
DATA QUALITY ANALYST
University of Mississippi Medical Center
01.2016 - 11.2016
CLINICAL TRIALS COORDINATOR
University of Mississippi Medical Center
01.2011 - 01.2016
PERFORMANCE IMPROVEMENT COORDINATOR
University of Mississippi Medical Center
08.2009 - 01.2011
COMPLIANCE ANALYST
University of Mississippi Medical Center
09.2003 - 08.2009
BACHELORS IN HEALTH INFORMATICS AND INFORMATION -
University of Mississippi Medical Center
ASSOCIATES IN HEALTH INFORMATION TECHNOLOGY -
Hinds Community College