Beverly Carroll
Oil City
Overview
15
15
years of professional experience
Work History
Regulatory Affairs Specialist
Sarah Cannon
07.2022 - Current
- Facilitated timely review and triage of IND applications, streamlining approval processes.
- Maintained FDA and GCP regulatory documentation for sites, studies, sponsors, and networks, ensuring compliance with local SOPs for format and content.
- Modified and developed informed consent forms, managing protocol and consent form amendments in compliance with IRB policy and HIPAA.
- Processed Safety Reports as delegated by the Principal Investigator, ensuring compliance with Institutional Review Board (IRB) reportable criteria.
- Organize and coordinate IRB documentation for trials.
- Establish and maintain a document management system for regulatory paper and electronic files.
- Maintain updated physician credentials for network participants and other critical documentation ensuring compliance.
- Informed Regulatory Affairs Manager and Network Management of all study and site-specific regulatory issues for guidance.
- Assist any internal or external audit team with any regulatory related issues.
- Archive study specific regulatory documentation and correspondence.
Director, Clinical Research
Louisiana Research Center
10.2010 - 07.2022
- Identified and resolved operational, logistical, and regulatory challenges in clinical trials, ensuring compliance and efficiency.
- Supervised and trained clinical research coordinators and regulatory staff, enhancing team capabilities and knowledge.
- Assisted with study start-up and closeout activities, including managing 1572 forms, informed consents, and continuing reviews.
Education
Business Diploma -
Ayers School of Business
01-1975
High School Diploma -
Parkway High School
01-1974
Skills
- Regulatory compliance
- Regulatory documentation
- IND submission
- IRB coordination
- Clinical trial oversight
- Document management
Timeline
Regulatory Affairs Specialist
Sarah Cannon
07.2022 - Current
Director, Clinical Research
Louisiana Research Center
10.2010 - 07.2022
Business Diploma -
Ayers School of Business
High School Diploma -
Parkway High School