Barbara Early Young RN BSN
Pittsburgh,PA
Summary
Skilled Clinical Research Associate with an international track record of success in progressively responsible positions in clinical environments. Experienced in monitoring multiple site locations, clinical site evaluation, initiation, maintenance and close/out visits in accordance with GCP and company SOPs, while ensuring integrity and study data including following study timelines. Skilled in applying applicable clinical research regulatory requirements such as GCP and ICH guidelines.
Overview
16
16
years of professional experience
Work History
Clinical Research Monitor
University Of Pittsburgh LITES
08.2007 - Current
- Monitor the conduct of clinical trials, especially enrollment and quality of data.
- Verify subject safety and site adherence to FDA Regulations and ICH/GCP Guidelines.
- Ensure Adverse Events are reported appropriately, accurately and in a timely manner and that follow-up activities are conducted as necessary.
- Review CRF, Informed Consent Documents and query language/narratives.
- Acquire specific clinical and therapeutic knowledge related to studies monitored.
- Conduct Qualification, Initiation, Interim and Closeout monitoring visits.
- Ensure complete and thorough study drug reconciliation.
- Manage trip reports, letters, query resolutions and expenses.
- Manage site master file contents and work with sites to ensure communication requirements between site and IRB are adhered to.
- Provide support and timely follow-up for all audit and quality assurance activities.
Education
Bachelor of Science - Nursing
Slippery Rock University of Pennsylvania
Slippery Rock, PA06.2010
Skills
- Ethics in Clinical Research
- International Conference on Harmonization Guidelines (ICH)
- Regulatory requirements: FDA and Drug Control, Drug and Cosmetic Act
- Health Insurance Portability and Accountability Act (HIPAA)
- Investigational New Drug Application (IND), New Drug Application (NDA)in Therapeutic Products Directorate (TPD)
- Coordination skills
- Monitoring:- Pre-study, Site Initiation, Interim Visit and Close-Out
- Reporting and Documentation
- Creative Problem Solving
- Interpersonal and Communication Skills
- Multi-Task Management
- Project Management
Accomplishments
- Progressive 15 years of professional experience in clinical trial monitoring
- Deep knowledge of monitoring procedures.
- Detailed knowledge of GCP and ICH guidelines including basic understanding of regulatory requirements.
- Excellent knowledge of clinical trial process.
- Comprehensive knowledge of clinical practices, clinical trial monitoring and design controls
- Familiar with the practices and methods of clinical trial methodology and research
- Extensive knowledge of clinical trial management systems as well as the design and implementation of clinical plans
- Strong communication, good interpersonal, organizational, and management skills
- Excellent attention to detail and diverse cultural awareness
Timeline
Clinical Research Monitor
University Of Pittsburgh LITES
08.2007 - Current
Bachelor of Science - Nursing
Slippery Rock University of Pennsylvania
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