Regulatory Affairs Manager
Open To Work
Rachael Duffin
UNIVERSITY OF MISSISSIPPI MEDICAL CENTER
Jackson,MS
1
Certificate
9
Years of experience
Dynamic Regulatory Affairs Manager with extensive experience at the University of Mississippi Medical Center. Expert in regulatory submissions, compliance, and Good Clinical Practice, demonstrating exceptional collaboration and detail orientation. Proven track record in managing complex clinical trials and enhancing operational efficiency, ensuring compliance with IRB and FDA regulations.
Work History
7 Months
04.2026 - Current
7 Months
Regulatory Affairs Manager
UNIVERSITY OF MISSISSIPPI MEDICAL CENTER | Jackson, MS
04.2026 - Current
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Worked with governance committees to make and evaluate plans.
- Prepared and maintained document inventory for core dossier preparation.
- Worked with internal team members to accomplish regulatory goals and achieve full compliance with all products.
3 Years 5 Months
11.2022 - 04.2026
3 Years 5 Months
Clinical Research Coordinator
UNIVERSITY OF MISSISSIPPI MEDICAL CENTER | Jackson, MS
11.2022 - 04.2026
- Coordinated planning, development, and implementation of Good Clinical Practice (GCP) research protocols and consent documents per IRB guidelines
- Collaborated with physicians, Principal Investigators, nurses, pharmacists, and healthcare professionals on clinical studies
- Documented adverse events, protocol deviations, and issues during clinical trials
- Prepared informed consent forms in compliance with applicable IRB regulations
- Screened, recruited, enrolled, consented, and retained eligible research participants while ensuring documentation accuracy
- Communicated with sponsors regarding protocol changes or updates throughout studies
- Prepared, modified, and submitted startup and IRB-approved study documents to central and local Institutional Review Boards
10 Months
01.2022 - 11.2022
10 Months
Clinical Research Regulatory Specialist
UNIVERSITY OF MISSISSIPPI MEDICAL CENTER | Jackson, MS
01.2022 - 11.2022
- Prepared and submitted regulatory documentation, including study start-up materials and informed consent forms
- Maintained compliance with federal, state, and local regulations for clinical research operations
- Ensured adherence to UMMC, FDA, and ICH policies and procedures throughout all projects
- Completed regulatory assessments to support project initiatives while guiding principal investigators
- Utilized Good Clinical Practice (GCP) and adhered to HIPAA guidelines in all processes
- Reviewed regulatory submissions for both domestic and international projects to ensure accuracy
- Coordinated submission of protocols and amendments to local and external IRBs, sponsors, and agencies
2 Years
06.2018 - 06.2020
2 Years
Researcher III
UNIVERSITY OF MISSISSIPPI MEDICAL CENTER | Jackson, MS
06.2018 - 06.2020
- Conducted extensive studies on preeclampsia, seizures, blood-brain barrier, and reduced uterine perfusion pressure
- Independently executed complex experiments, compiling and analyzing data with various software applications
- Prepared and maintained experimental animals while modifying research techniques in collaboration with lab members
- Recorded procedures and results, maintaining thorough documentation of laboratory activities
- Monitored and prepared lab equipment, adhering to strict safety protocols
- Participated in brainstorming sessions to develop innovative project ideas for grant proposals
- Presented complex research findings at conferences in an engaging manner
1 Year
06.2017 - 06.2018
1 Year
Int. Access Financial Coordinator
UNIVERSITY OF MISSISSIPPI MEDICAL CENTER | Jackson, MS
06.2017 - 06.2018
- Used the EPIC (EMR) system to access patient charts, register and transfer using the hospital's EPIC database
- Provided exceptional customer service to everyone who enters the facility
- Answer high-volume phone calls during the shift
- Obtain demographics, insurance, medical information, and process co-pays and deposits
- Identified areas of cost savings and increased efficiency in financial operations
Education
Master of Science (MS) - Biology
Alcorn State University | Lorman | 05.2016
- 3.54 GPA
Bachelor of Science - Biology Health Science
Alcorn State University | Lorman | 12.2014
- 3.02 GPA
Some College (No Degree) - Nursing
Mississippi College | Clinton, MS, US
Skills
Regulatory and Compliance maintenance / start-up institutional review board submissions (Advarra
WcgIRB
Cayuse)
Good clinical practice
REDCap proficiency
Industry and investigator-initiated clinical trials
Phlebotomy skills
Laboratory processing and shipping
Certification
October 29, 2024- West Virginia University
ISCORE-RC- Clinical Research Coordinator
Work Preference
Work Type
Full Time
Location Preference
On-SiteRemoteHybrid
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Regulatory Affairs Manager
UNIVERSITY OF MISSISSIPPI MEDICAL CENTER
04.2026 - CurrentRead more
Clinical Research Coordinator
UNIVERSITY OF MISSISSIPPI MEDICAL CENTER
11.2022 - 04.2026Read more
Clinical Research Regulatory Specialist
UNIVERSITY OF MISSISSIPPI MEDICAL CENTER
01.2022 - 11.2022Read more
Researcher III
UNIVERSITY OF MISSISSIPPI MEDICAL CENTER
06.2018 - 06.2020Read more
Int. Access Financial Coordinator
UNIVERSITY OF MISSISSIPPI MEDICAL CENTER
06.2017 - 06.2018Read more
Alcorn State University - Master of Science (MS), Biology
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Alcorn State University - Bachelor of Science, Biology Health Science
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Mississippi College - Some College (No Degree), Nursing
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Profile Websites
Online Profile Link
https://bold.pro/my/duffin0112