Gloria Dorsette
Durham,NC
Summary
Senior Regulatory and IRB Compliance Professional with 10+ years of experience advancing ethical research practices across academic and clinical institutions. Skilled in IRB operations, regulatory interpretation, protocol review, and compliance training. Experienced in advising faculty, students, and staff on research ethics, IRB compliance, and regulatory frameworks. Recognized for analytical expertise, meticulous attention to detail, and commitment to research integrity within higher education and healthcare settings.
Overview
11
11
years of professional experience
Work History
Regulatory/ IRB Compliance Officer
North Carolina Central University
Durham, NC
10.2024 - Current
- Advise faculty, staff, and students on ethical human and animal research practices, providing regulatory interpretation aligned with federal, state, and institutional IRB standards.
- Develop, revise, and implement institutional SOPs and policies for research compliance.
- Collaborate with leadership and external regulatory agencies to ensure compliance with OHRP, NIH, and state research requirements.
- Conduct regulatory and compliance reviews of human research protocols to ensure adherence to federal regulations (45 CFR 46, FDA, OHRP) and institutional policies.
- Analyze research submissions and identify compliance gaps, providing recommendations to investigators to mitigate risks and ensure protocol alignment.
- Develop and implement SOPs and compliance frameworks to improve audit readiness and regulatory adherence.
- Generate compliance reports and provide training to faculty and staff on regulatory requirements and ethical research practices.
- Collaborate with institutional leadership and regulatory bodies to maintain continuous inspection readiness.
- Increased IRB compliance and efficacy by 40% by implementing SOPs, introducing tracking systems for protocol compliance.
Senior Study Manager ( Cardiology)
ICON/PRA Health Sciences
Raleigh, NC
08.2022 - 08.2023
- Oversaw multiple clinical trials, ensuring compliance with GCP, FDA regulations, and sponsor requirements.
- Analyzed study performance data and metrics to identify risks, trends, and operational inefficiencies.
- Prepared and submitted IRB applications, amendments, and regulatory documentation in alignment with compliance standards.
- Improved study start-up timelines by 30% through workflow optimization and process improvements.
- Partnered with cross-functional teams to support audit readiness and regulatory inspections.
Senior Study Manager (Oncology Drug and Device)
Premier Research
Durham, NC
02.2020 - 08.2022
- Led regulatory and IRB submission processes for oncology trials, ensuring adherence to ICH-GCP and institutional policies.
- Evaluated study documentation and processes to identify quality risks and implement corrective actions.
- Developed documentation standards to enhance audit readiness across multiple study sites.
- Provided training and mentorship to research staff on compliance, protocol adherence, and documentation quality.
In-House Clinical Research Associate (Oncology)
Aerotek
Durham, NC
09.2019 - 01.2020
- Reviewed and tracked regulatory and investigator documents to ensure completeness and compliance.
- Maintained accurate records in CTMS and eTMF systems to support audit readiness.
- Identified documentation gaps and collaborated with sites to resolve discrepancies.
Clinical Data Coordinator ( Oncology)
Synteract, HRC
Morrisville, NC
07.2018 - 09.2019
- Reviewed and validated clinical trial data in EDC systems (e.g., Medidata RAVE) to ensure data integrity and compliance.
- Analyzed datasets to identify discrepancies, trends, and protocol deviations.
- Collaborated with study teams to resolve data issues and maintain high-quality submissions.
Study Start-Up Specialist (Neurology)
Syneos Health
Raleigh, NC
07.2017 - 07.2018
- Prepared and submitted regulatory documentation, including IRB applications and informed consent forms.
- Streamlined start-up processes, reducing timelines by 30% while maintaining compliance.
- Supported regulatory readiness and documentation quality for clinical trials.
Regulatory Associate (Contractor) ( Oncology)
UNC Chapel- Hill
Chapel Hill, NC
01.2017 - 07.2017
- Managed IRB submissions for investigator-initiated and NIH-funded trials.
- Developed CAPAs and contributed to regulatory submissions (IND/NDA support).
- Assisted in SOP development to strengthen compliance processes.
Lead Clinical Research Regulatory Administrator
Novant Health
Durham, NC
12.2014 - 12.2016
- Oversaw IRB submissions, approvals, and continuing reviews for multi-site studies.
- Conducted investigator and staff training to ensure adherence to ethical research standards.
- Managed IRB submissions, approvals, and continuing reviews; ensured full regulatory compliance for multi-site clinical studies.
- Conducted staff training and site meetings, promoting adherence to ethical research standards.
- Conducted compliance training and ensured adherence to regulatory and ethical standards.
- Supported audit preparation and maintained regulatory documentation.
Education
MASTER'S DEGREE - Human Growth and Development
North Carolina Central University
DurhamBACHELOR'S DEGREE - Biology minor Chemistry
North Carolina Central University
Durham, NCBACHELOR'S DEGREE - Exercise Sport Science
North Carolina Central University
Durham, NCSkills
- Data analysis and oversight
- CTMS ( Medidata RAVE, Oncore, Veeva Vault)
- Proficient in ETMF systems
- Proficiency in ICH-GCP regulations
- Compliance assessment and evaluation
- Experience with FDA compliance standards
- Data-driven risk evaluation
- Compliance readiness
- Data accuracy evaluation
- Data-driven decision making
- Mentorship and skill development
- Data analysis and reporting from CTMS
- Collaborating across departments
Affiliations
- Public Responsibility in Medicine and Research (PRIM&R)
Personal Information
Title: Clinical Research Professional
Timeline
Regulatory/ IRB Compliance Officer
North Carolina Central University
10.2024 - Current
Senior Study Manager ( Cardiology)
ICON/PRA Health Sciences
08.2022 - 08.2023
Senior Study Manager (Oncology Drug and Device)
Premier Research
02.2020 - 08.2022
In-House Clinical Research Associate (Oncology)
Aerotek
09.2019 - 01.2020
Clinical Data Coordinator ( Oncology)
Synteract, HRC
07.2018 - 09.2019
Study Start-Up Specialist (Neurology)
Syneos Health
07.2017 - 07.2018
Regulatory Associate (Contractor) ( Oncology)
UNC Chapel- Hill
01.2017 - 07.2017
Lead Clinical Research Regulatory Administrator
Novant Health
12.2014 - 12.2016
MASTER'S DEGREE - Human Growth and Development
North Carolina Central University
BACHELOR'S DEGREE - Biology minor Chemistry
North Carolina Central University
BACHELOR'S DEGREE - Exercise Sport Science
North Carolina Central University