CINDY L. RENZ
Brooksville,FL
Summary
Accomplished Clinical Research Associate with 6.5 years of experience performing and documenting pre-study site evaluations, regulatory document collection, interim monitoring and study close-out visits. Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. In-depth knowledge of company procedures, regulatory requirements and quality standards.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Clinical Research Associate (Senior CRA3)
IQVIA
11.2018 - Current
- Monitoring the progress of clinical studies to ensure clinical trials are conducted, recorded and reported in accordance with the protocol, standard operating procedures, ICH-GCP, and all applicable regulatory requirements.
- Site management, training and education of 28 sites on trial protocols.
Associate Director of Alzheimer’s Services/Educator
Meridien Research
06.2018 - 11.2018
- Community Outreach, Caregiver Support Group Leader and provider of education and resources to study subjects, caregivers and coordinators.
- Trained and developed department leaders and management staff for specific projects and ongoing operational needs.
RN/Clinical Research Coordinator/Educator
Meridien Research
01.2012 - 01.2018
- Employee educator, mentoring new employees and site wide quality assurance and quality improvement.
- Developed coordinator training program.
- Certified rater for psychometric and global assessments.
- All aspects of research coordination including patient education, obtaining informed consent, conducting study visits, regulatory documentation, data management and working closely with study sponsors.
Education
Masters of Science - Nursing Leadership and Management
WGU
Salt Lake City, UT04.2017
Bachelors of Science - Nursing
WGU
Salt Lake City, UT05.2015
Associate in Science - Nursing
PHSC
New Port Richey, FL06.1995
Skills
- Registered Nurse
- Clinical Research Associate
- ACLS-BLS-CPR/AED
- IATA
- Psychometric/Global Rating
- CITI- ICH/GCP training
- Microsoft Office- Word, Excel, Powerpoint
- Electronic Medical Record/databases
- Electronic Regulatory systems
Professional Highlights
- Registered Nurse with diverse background.
- Sr. CRA3 research experience in Neurology, CNS, Psychiatry, Immunology and various indications.
- Clinical monitoring in all aspects of research phases from site selection to close-out; protecting subject safety as well as ensuring all subject data is reviewed for accuracy and is captured within the protocol requirements.
- Management of site issues and study documentation with strong clinical, organizational and communication skills.
Certification
- State of FL Registered Nurse License - 1995-present
Languages
English
Timeline
Clinical Research Associate (Senior CRA3)
IQVIA
11.2018 - Current
Associate Director of Alzheimer’s Services/Educator
Meridien Research
06.2018 - 11.2018
RN/Clinical Research Coordinator/Educator
Meridien Research
01.2012 - 01.2018
Masters of Science - Nursing Leadership and Management
WGU
Bachelors of Science - Nursing
WGU
Associate in Science - Nursing
PHSC
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