Nina Pogorzelski
San Antonio,TX
Summary
With over five years of experience in military medical research and over 15 years of experience in the legal, justice, audit, and investigation industry, I am a seasoned Senior Regulatory Affairs Specialist at the Henry M. Jackson Foundation (HJF).
I work for the Defense Health Agency (DHA) Public Health Directorate, Immunization Healthcare Division, managing regulatory affairs for five states and the National Capital Region. I am responsible for ensuring compliance with federal, state, and institutional regulations and policies for clinical trials involving vaccines and immunizations. I have extensive experience in and with various Institutional Review Boards and Human Research Protections Offices in the military sphere.
I have a Master of Science in Health Sciences with a focus on Regulatory Affairs from the George Washington University School of Medicine and Health Sciences. I have developed and applied my skills in process improvement, clinical protocols, and data analysis to support the DHA's mission of safeguarding the health and well-being of the military community.
I am passionate about advancing the field of military medicine and contributing to quality regulated research. I collaborate with a diverse and talented team of researchers, clinicians, and stakeholders to facilitate and enable ethical and high-quality research.
Overview
15
15
years of professional experience
1
1
Certification
Work history
Senior Regulatory Affairs Specialist
Henry M. Jackson Foundation
San Antonio
2022.08 - Current
- Manage and track regulatory review of COVID, Smallpox, Yellow Fever, Anthrax, Genetic Analysis study protocols from physician investigators from all regional hubs nationally (Fort Bragg, NC, Walter Reed, NCR, NMC San Diego, Seattle, WA, Fort Hood, TX, Ft Sam Houston, TX, Lackland AFB, TX).
- Subject Matter Expert (SME) in Human Subject Research Protection and consultant for Human Subjects Research and Clinical Investigation for all research conducted for DHA Immunization Healthcare Division (IHD)
- Develop strong site relationships and ensure continuity of site relationships through all phases of the trial
- Provide leadership and direction for the Immunization Healthcare Division
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOP, Protocol, and other documents.
- Develop a Research Guidance/Standard Operating Procedures for researchers within DHA with coordination from other Military Treatment Facilities (MTF) Human Research Protections Office and Institutional Review Boards
- Provide advise/guidance to Principal Investigator and study team on (complex) regulatory affairs/ human subjects protection issues.
- Identifies, assesses, and resolves site performance, quality or compliance problems and escalate as appropriate
- Inspect study binders for compliance and accuracy
- Maintain staff CITI/research training records for compliance
- Conduct full regulatory reviews of protocol and supplemental documents for uniformity and non-scientific issues
- eIRB Super User. Trained staff on the use of eIRB and provided other research related training and regulatory updates via bulletin
- ClinicalTrials.gov WAMC Account holder
- Led regularly scheduled study meetings and teleconferences with internal and external stakeholders for status updates and to identify risks and plan mitigation strategies.
- Experience with all MTF HRPO and IRBs, to include NMCPortsmouth, NMCSD, SAIRB, Walter Reed IRB, DHA IRB, and communicate gaps in processes.
- Maintained accurate and detailed compliance records.
- Developed policies and systems to ensure business successfully achieved objectives.
- Ensured company policies were implemented and adhered to.
- Reported audit results to identify and evaluate opportunities for improvement.
- Met stringent deadlines with precise prioritisation and strong knowledge of compliance requirements.
- Assessed company SOPs and implemented processes for standardised reviews and updates.
- Liaised with external certifying agencies to verify compliance or clarify corrective actions.
- Prepared professional business correspondence to initiate or resolve regulatory actions and keep businesses informed.
- Compiled relevant legal and administrative documents relating to inspections.
- Promoted importance of proper regulatory knowledge throughout daily work.
- Explained technical regulations to non-technical customers in clear and concise manner.
Regulatory Affairs Specialist
MD Consulting LLC
San Antonio
2021.11 - 2022.08
- Manage and track regulatory review of COVID, Smallpox, Yellow Fever, Anthrax, Genetic Analysis study protocols from physician investigators from all regional hubs nationally (Fort Bragg, NC, Walter Reed, NCR, NMC San Diego, Seattle, WA, Fort Hood, TX, Ft Sam Houston, TX, Lackland AFB, TX).
- Provide leadership and direction for the Immunization Healthcare Division
- Subject Matter Expert (SME) in Human Subject Research Protection and consultant for Human Subjects Research and Clinical Investigation for all research conducted for DHA Immunization Healthcare Division (IHD)
- Develops strong site relationships and ensures continuity if site relationships through all phases of the trial
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOP, Protocol, and other documents.
- Develop a Research Guidance/Standard Operating Procedures for researchers within DHA with coordination from other Military Treatment Facilities (MTF) Human Research Protections Office and Institutional Review Boards
- Provide advise/guidance to Principal Investigator and study team on (complex) regulatory affairs/ human subjects protection issues.
- Inspect study binders for compliance and accuracy
- Maintain staff CITI/research training records for compliance
- Conduct full regulatory reviews of protocol and supplemental documents for uniformity and non-scientific issues
- Liase with other regulatory bodies/OHRP to close gap in regulatory inconsistencies and suggest solutions
- eIRB Subject Matter Expert. Trained staff on the use of eIRB and provided other research related training and regulatory updates via bulletin
- ClinicalTrials.gov WAMC Account holder
- Led regularly scheduled study meetings and teleconferences with internal and external stakeholders for status updates and to identify risks and plan mitigation strategies.
- Experience with all MTF HRPO and IRBs, to include NMCPortsmouth, NMCSD, SAIRB, Walter Reed IRB, DHA IRB, and communicate gaps in processes.
- Maintained accurate and detailed compliance records.
- Developed policies and systems to ensure business successfully achieved objectives.
- Ensured company policies were implemented and adhered to.
- Reported audit results to identify and evaluate opportunities for improvement.
- Met stringent deadlines with precise prioritisation and strong knowledge of compliance requirements.
- Assessed company SOPs and implemented processes for standardised reviews and updates.
- Liaised with external certifying agencies to verify compliance or clarify corrective actions.
- Prepared professional business correspondence to initiate or resolve regulatory actions and keep stakeholders informed.
- Compiled relevant legal and administrative documents relating to inspections.
- Promoted importance of proper regulatory knowledge throughout daily work.
- Explained technical regulations to non-technical customers in clear and concise manner.
Institutional Review Board Analyst
Regional Health Command- Central
Fort Sam Houston
2020.06 - 2021.11
- Managed review of study protocol submissions from physician-investigators, residents, fellow, faculty, and other non-medical scientists.
- Provided regulatory direction to investigators and stakeholders on Regional Health Command- Central Institutional Review Board (IRB) and Human Research Protections Office (HRPO) matters.
- Back up agenda preparer for IRB meetings
- Prepared Approval Memos and Minutes for newly approved research studies
- Served as the analyst for the initial review and determination/approval of Expedited, Exempt, and Research Not Involving Human Subjects study protocols, and back up analyst for Amendment submission.
- Served as the hospital appointed Financial Liability Investigating Officer for a specific assignment regarding TSMP-human tissue loss and lost medical equipment. Provided my findings and other material relevant to the FLIPL cases.
- Evaluated policies, procedures, and best practices that pertained to the department.
- Contributed to monthly metrics for distribution to Regional Health Command- Central and hospital command.
- Worked closely with investigators and regulatory officials to achieve understanding of scientific and administrative concerns.
- Monitor, interpret, and apply multiple levels in current legislative, regulatory, and policy guidance.
- Work with all MTF HRPO and IRBs, to include NMCPortsmouth, NMCSD, Walter Reed IRB, DHA IRB, and communicate gaps in processes.
- Maintained smooth operations through careful management of office workflow and administrative processes.
- Kept accurate company records, upholding compliance with regulations and company policies.
- Helped teams strengthen internal controls and departmental processes to bring errors to near-zero.
- Provided advice to management regarding company strengths and weaknesses.
Research Project Manager
Womack Army Medical Center
Fort Bragg
2018.08 - 2020.05
- Efficient or had experience with the following databases: AHLTA, CHCS, ProVation, Essentris, Airview Resmed, Electronic Institutional Review Board (eIRB), DoD Trauma Registry (DoDTR), and S3
- Managed 25+ research projects from various clinics within the hospital (Orthopaedics, DENTAC, Anesthesiology, Pain Clinic, Family Medicine, Internal Medicine, General Surgery, Pediatrics, Interventional Radiology and Radiology)
- Ensured compliance with applicable laws, regulations, & Standing Operating Procedures (SOP) as it pertained to medical research (i.e., Good Clinical Practice (GCP))
- Liaison for grant managers, statisticians, resident/physicians, investigators, Geneva Research Coordinators, medical librarians, & external civilian and military institutions.
- Aided with study design/start up, protocol writing, Informed Consent document writing, data collection/obtain medical records, analysis, A3 and department-wide process improvement projects (focus being on rerouting of referrals, providing holistic health options for hospital employees like group yoga, meditation etc., and introducing tai chi in the musculoskeletal training program), the WAMC research symposium, and the publication clearance process.
- Managed project timelines, grant proposals, interim and final reports to the sponsor/funding agencies.
- Led regularly scheduled study meetings and teleconferences with internal and external stakeholders for status updates and to identify risks and plan mitigation strategies.
- Trained research coordinators on the use of eIRB, the research process in general, and the study protocol for better understanding.
- Drafted standard operating procedures and guidelines for project management
- Attended Regional Health Command- Atlantic (RHC-A) Institutional Review Board meetings and Scientific Review Committee meetings on a quarterly basis
- Received hands-on training by Orthopaedic research staff at Carolinas Medical Center (Atrium Health- Charlotte NC) in preparation for the Major Extremity Trauma Research Consortium (METRC) Mobility Toolkit study.
- Acted as single point of contact for customers and internal stakeholders.
- Delivered on projects' key objectives with agreed budgets, timelines and standards.
- Embedded lean governance operating models, valuing ownership, predictability and transparent delivery over pre-prepared project reporting.
- Identified and deployed resources with individual responsibilities for project completion.
- Defined risk profiles for each project and prepared contingency plans to minimise business risk.
- Assured project documentation followed internal quality standards.
- Streamlined multiple plans and dependencies across range of teams into single overarching perspectives and plans.
- Built and nurtured professional relationships with wide range of stakeholders.
Paralegal
Federal Energy Regulatory Commission
Washington, District of Columbia
2017.01 - 2018.01
- repared and processed numerous certifications, notices, subpoenas, and procedural orders ensuring that all documents were correct and met all Commission requirements.
- Provided administrative support and management information system support to two administrative law judges, who are responsible for handling adjudicatory matters for the Commission.
- Managed the judges’ cases for two judges by maintaining logs of incoming and outgoing legal documents, orders, exhibits, etc. from institution of proceeding to final termination of hearing phase of a case.
- Communicated case-related information to FERC staff and involved parties.
- Maintained extensive contact with staff members, representatives of regulated companies, members of the public and other officials throughout the Commission.
- Developed, maintained, and created procedural guidelines and checklists to supplement established procedures.
- Analysed elements of civil litigation, including evidence gathering and presentation and client counselling.
- Developed legal documents, including motions and briefs, to support litigation processes and court proceedings.
- Communicated pertinent information to clients via phone, email and mail.
- Researched state statutes, decisions, legal articles, codes and documents.
- Utilised a broad range of research tools, including online databases and examined statutory law, case law and federal and state regulations.
- Managed the legal department for superior court judges.
- Acted as liaison between multiple attorneys involved in complex legal issues.
Engagement Officer
Asian Pacific American Employee, Federal Energy Regulatory Commission
Washington, District of Columbia
2017.01 - 2018.01
- Ensured that the APA ERG members’ views are collected at all levels and channeled to the co-chairs and chairman of the board.
- Delivered programs proposals to the co-chairs and once approved, provide oversight of the process from beginning to end.
- Sought progression opportunities for our members and build relationships with other Employee Resource Groups for collaboration, such as the diversity fair.
- Coordinated with the APA-FERC accountant and the Equal Employment Office (EEO)on finance matters related to our events as well as the Ethics attorney for matters concerning donations.
Auditor
DoD Office of Inspector General
Alexandria, Virginia
2016.03 - 2017.01
- Performed several planning related tasks including assisting auditors in updating the team’s 12-week audit plan and creating a detailed travel estimate for 3 potential audit verification sites.
- Created a multi-page first draft point paper that supplemented an accepted FY 2017 Fact Sheet for a follow-on review of Marine Corps ESPC location.
- Traveled with the audit team to Port Hueneme, California for a site visit at the NAVFAC Engineering and Expeditionary Warfare Center.
- Conducted interviews, and took part in teleconferences, prepared correspondence, researched Navy laws, applicable Federal, Department of Defense (DOD), Department of Energy (DOE), directives, and regulations (Generally Accepted Governmental Auditing Standards (GAGAS) Federal Acquisition Regulation (FAR) DFARs etc...), manuals, and audit reports related to ESPCs.
- Aided in requesting Navy ESPC Contracting Officer Representative (COR) letters, contracts, COR training, quality assurance surveillance plans via Excel spreadsheets, contract files and CDs prepared by the contracting officer.
- Aided other auditors in preparing planning debrief data sheets for 5 selected high dollar value Navy ESPC projects to identify attributes such as lack of annual validation reviews and CORs.
- Ensured the adequacy of internal controls and minimizing the risk of fraud, waste, and abuse.
- Conducted data collection and analysis from the proper sources to make proposals or recommendations to resolve issues and experience with assisting with scheduling and organizing projects, meetings, and conducting training.
- Reviews and evaluates evidence and findings to determine compliance with DoD laws and regulations.
- Planned and executed audits to validate records and systems for compliance with Generally Accepted Accounting Principles (GAAP).
- Applied auditing expertise and industry knowledge to consistently complete quality audits on schedule.
- Minimised risk by maintaining up to date knowledge on industry and regulatory changes impacting audit operations.
- Checked large and complex data sets to identify controls failures, fraud and concerning trends.
- Compiled and organised extracted data for review and analyses.
- Helped teams strengthen internal controls and departmental processes to bring errors to near-zero.
Paralegal
Law Office of Ronald K. Seastrunk
Leesville, Louisiana
2015.01 - 2015.11
- Produced information by transcribing, formatting, inputting, retrieving, copying, and transmitting text data and graphics, coordinating case preparation.
- Conserved attorney’s time by reading, researching, reviewing, verifying, and routing correspondence, reports, and legal documents; drafting letters and documents; collecting and analyzing information; initiating telecommunications; organizing client conferences, and attorney meetings; scheduling couriers, court reporters, expert witnesses, and other special functions; coordinating preparation of charts, graphs, and other courtroom visuals; preparing expense reports.
- Recorded and monitored court appearance dates, pleadings, and filing requirements while monitoring evidence.
- Anticipated changes in litigation or transaction preparation requirements.
- Represented the attorney by communicating and obtaining information on his behalf; and following up on delegated assignments, knowing when to act and when to refer matters to him.
- Generated revenue by documenting and inputting attorney billable time and reimbursable expenses; preparing invoices and tracking payments.
- Consistently ensured operation of equipment by completing preventative maintenance requirements. I called for repairs when necessary, and updated job knowledge by taking part in educational opportunities.
- Analysed elements of civil litigation, including evidence gathering and presentation and client counselling.
- Developed legal documents, including motions and briefs, to support litigation processes and court proceedings.
- Communicated pertinent information to clients via phone, email and mail.
- Implemented emergency procedures to save time and spearhead specific legal projects.
- Utilised a broad range of research tools, including online databases and examined statutory law, case law and federal and state regulations.
- Reviewed Deed of Trust, Title Commitment and prior bankruptcies documents.
Child and Youth Program Assistant
Child and Youth Services
Fort Polk, Louisiana
2014.04 - 2014.07
- Led planned activities for program participants.
- Supervised children and youth during daily schedule of indoor and outdoor activities, on field trips, outings and special events and promoted and modeled safety, fitness, and health and nutrition practices.
- Maintained program participation data and completing required daily reports.
- Provided care/supervision, oversight, and accountability for program participants in compliance with DoD, Army and local policies, guidance, and standards. I completed designated training requirements, recorded, and tracked completed training on own Individual Development Plan (IDP).
- Participated in program evaluation as required and assisted in achieving and maintaining DoD/Army certification and national accreditation or Army equivalent.
- Worked with large team to complete daily tasks to schedule.
- Closely monitored child wellbeing, regularly updating parents to assure continued safety and security.
- Regularly utilised multi-tasking expertise to ensure multiple children's needs were effectively met.
- Wrote up regular activity and observations reports, monitoring children's progress and development.
- Supported children to identify and manage their feelings and behaviours.
- Promoted internal policies, external legislation and regulatory guidelines.
- Established and maintained positive relationships with parents, carers and nursery staff.
Military Police Officer
US Army
Fort Bragg, North Carolina
2008.05 - 2010.09
- Monitored and authorized entrance and departure of employees, and visitors to guard against theft and maintain security of premises.
- Wrote reports of daily activities and irregularities, such as equipment or property damage, theft, presence of unauthorized persons, or unusual occurrences.
- Answered alarms and investigate disturbances such as domestic abuse within on post housing, circulated among visitors, patrons, or employees to preserve order and protect property, and patrolled industrial or commercial premises to prevent and detect signs of intrusion and ensure security of doors, windows, and gates.
- Transported detained individuals from off-post police station to process them on-post.
- Operated detecting devices to screen individuals and prevent passage of prohibited articles into restricted areas.
- Warned persons of rule infractions or violations, and apprehend or evict violators from premises, using force when necessary.
- Conducted traffic stops and used force when necessary.
- Used proven interview techniques to garner reliable evidence and statements from victims, witnesses and suspects.
- Produced comprehensive crime reports with meticulous attention to detail.
- Responded quickly to emergency situations, leading calm and effective negotiations with suspects to diffuse highly charged situations.
- Assessed and verified information given in victim and witness statements to improve investigation workflow.
- Maintained strict confidentiality through careful and correct storage of case documents, in line with internal policies.
- Aided investigations through strategic interviewing and statement taking of victims, suspects, witnesses and informants.
- Maintained optimal street coverage by planning and managing patrolling schedules.
Education
Master of Science - Regulatory Affairs
George Washington University
Washington, District of Columbia2021
Bachelor of Science - Business Administration
Purdue University
West Lafayette, Indiana2018
Associates of Applied Science - Business Administration
Sandhills Community College
Pinehurst, North Carolina2014
Skills
- Process analysis and improvement
- High-value project management
- Coaching and mentoring
- Customer relationship management
- eIRB expertise
- Technical Writing
- Project Management
- Clinical research
- Department management
- Mentoring and training
Accomplishments
- Honorable Mention- Federal Junior Duck Stamp Conservation and Design Program January 2006, by Department of the Interior- Maryland Division
- Certification of Appreciation- Department of the Army September 2016, by CPT Jon S. Donaldson
- Award for Quality Service (Monetary Award)- Federal Energy Regulatory Commission August 2017, by Chief Judge Carmen A. Cintron
- Certificate of Achievement- PJM Interconnection LLC
- Award for Quality Service (Monetary Award) Federal Energy Regulatory Commission December 2017, by Chief Judge Carmen A. Cintron
- Award for 5 years Federal service, May 2019, by COL John Melton
- Time Off Award- 12 hours, October 2019, Womack Army Medical Center
- Certificate of Appreciation- Musculoskeletal Course for Military Providers December 2019, by Medical Director of Robinson Health Clinic, COL Matthew Hing
- Time Off Award- 20 hours, July 2021, Brooke Army Medical Center
- Readiness Relevance of Society of Military Orthopaedic Surgeons (SOMOS) Annual Meeting Topics: A 10-Year Review. J Huh, A Adams, J Helms, R Card, NJ Pogorzelski, KJ Nelson. SOMOS Annual Meeting, Tampa, FL, Dec 18, 2019: e-Poster Presentation
- Readiness Relevance of Society of Military Orthopaedic Surgeons (SOMOS) Annual Meeting Topics: A 10-Year Review. J Huh, A Adams, J Helms, R Card, NJ Pogorzelski, KJ Nelson. Extremity War Injuries Symposium, Washington, DC, Jan 20-22, 2020: Oral Presentation
- Readiness Relevance of Society of Military Orthopaedic Surgeons (SOMOS) Annual Meeting Topics: A 10-Year Review. J Huh, A Adams, J Helms, R Card, NJ Pogorzelski, KJ Nelson. George Washington University Research Showcase, Washington D.C, April 7, 2020: ePublication
- Rheumatoid Arthritis (RA): A Skeletal Civil War. A body divided against itself cannot stand. NJ Pogorzelski. Womack Army Medical Center (WAMC) Research Day, Fort Bragg, NC, Apr 29, 2020: e-Poster Presentation
- The Sleepy Soldier: Predictors for PAP Adherence Among Active-Duty Military Personnel Newly Diagnosed with Obstructive Sleep Apnea. CPT Lea Choi, DO, Juliana S. Ee, PhD, Christopher K. Pham, DO, MAJ David P. Shaha, MD, Mary C. Rogers, RN, Greg S. Cacace, RPSGT, CPT Charles W. Mounts, DO, CPT Anna C. Sealander, MD, Nina Pogorzelski, BS, Yuliang Liu, PhD. Uniformed Services Academy of Family Physicians (USAFP) 2021 Annual Meeting, March 2021: Podium Presentation
- Incidence of Deep Vein Thrombosis (DVT) in Patients Using a Knee Scooter. Stuart J. Davidson, MD, Nina Pogorzelski, MHS, Thomas C. Dowd, MD, Jeannie Huh, MD. SOMOS 63rd Annual Meeting, Olympic Valley, CA, December 13-17, 2021: Poster Presentation
- Platelet Rich Plasma for Full-thickness Supraspinatus Tendon Tear and Tendinosis in a Special Operations Force Soldier. Kirk S. Russell, MD, Shawne R. Barnes, RRA, Nina Pogorzelski, MHS, Bill E. Ives Jr., APA-C, Craig Labuda, MD, Cristobal S. Berry-Caban, PhD, Y. Sammy Choi, MD. VII Annual Cape Fear Symposium, Fort Bragg, NC, Apr. 19, 2023: Poster Presentation
- Predictors of Positive Airway Pressure Therapy Adherence among Active-Duty Military Personnel Newly Diagnosed with Obstructive Sleep Apnea. Juliana Ee, PhD; Javier A. Saldana, MD; Lea S. Choi, DO; Christopher K. Pham, DO; David P. Shaha, MD; Godwin Y Dogbey, PhD, Nina Pogorzelski, MHS. Military Health System Research Symposium 2023 Annual Meeting, Kissimmee, FL, August 14-17, 2023: Oral Presentation
- Can a Behavioral Intervention Class Improve Adherence to Positive Airway Pressure Therapy for Active-Duty Military Personnel Newly Diagnosed with Obstructive Sleep Apnea? Juliana Ee, PhD; Charles W. Mounts, DO; Christopher K. Pham, DO; David P. Shaha, MD; Godwin Y Dogbey, PhD, Nina Pogorzelski, MHS; Lea S. Choi, DO. Military Health System Research Symposium 2023 Annual Meeting, Kissimmee, FL, August 14-17, 2023: Oral Presentation
- Role Player for U.S Army South Reintegration Team (July 2021- As needed)
- Working Group Member- A3 Process Improvement Project (July 2019-May 2020)
- Financial Liability Investigating Officer at Brooke Army Medical Center for a Temperature Sensitive Medical Product (TSMP) human tissue case. (Nov 2020)
- Financial Liability Investigating Officer at Brooke Army Medical Center for 2 lost medical equipment over $33,000. (Apr 2021)
- Softball coach at Hoke County Recreational Center, Raeford, NC (Mar 2018-May 2018)
- Bush M.S PTA 8th grade Dance/Pool Party Chair (August 2023-)
- Bush M.S PTA Financial Reconciliation Committee Member
- Bush M.S PTA Social Media Edit Committee Member
- Lifehouse Church Hospitality Team
Awards:
October 2017, by Instructor John W. Gdowik- For her exceptional achievement of operating the bulk power electric grid simulator in the most economical and reliable manner. She demonstrated her knowledge of Security Constrained Economic Dispatch with a very impressive assessment score that exceeded many of those who have attempted the challenge.
Presentations/Publications:
Volunteer:
Certification
- Basic Life Support for Healthcare Providers – Red Cross (Exp. Nov 2023)
- Researcher Mgmt & Leadership Training- University of Colorado School of Medicine (Completed Dec 2021)
- CITI Good Clinical Practice for Clinical Trials w/Investigational Drugs & Medical Devices (Exp. May 2024)
- CITI IRB Chairs (Exp May 2024)
- CITI Biomedical Investigators and Research Study Team (Exp May 2026)
- CITI Responsible Conduct for Research (Exp Dec 2024)
- FDA Regulatory Education for Industry Annual Conference 2021 (CDER)
- FDA Clinical Investigator Training Course 2022 (CDER/SBIA)
- PRIMR Member (current)
- PRIMR Certified IRB Professional certification in progress
- Northwestern University- High Performance Collaboration: Leadership, Teamwork, and Negotiation- In Progress
Additional Information
- Security Clearance: Active- Secret
Languages
Korean
Elementary
English
Fluent
Timeline
Senior Regulatory Affairs Specialist
Henry M. Jackson Foundation
2022.08 - Current
Regulatory Affairs Specialist
MD Consulting LLC
2021.11 - 2022.08
Institutional Review Board Analyst
Regional Health Command- Central
2020.06 - 2021.11
Research Project Manager
Womack Army Medical Center
2018.08 - 2020.05
Paralegal
Federal Energy Regulatory Commission
2017.01 - 2018.01
Engagement Officer
Asian Pacific American Employee, Federal Energy Regulatory Commission
2017.01 - 2018.01
Auditor
DoD Office of Inspector General
2016.03 - 2017.01
Paralegal
Law Office of Ronald K. Seastrunk
2015.01 - 2015.11
Child and Youth Program Assistant
Child and Youth Services
2014.04 - 2014.07
Military Police Officer
US Army
2008.05 - 2010.09
Master of Science - Regulatory Affairs
George Washington University
Bachelor of Science - Business Administration
Purdue University
Associates of Applied Science - Business Administration
Sandhills Community College