Susan K.S. Kwon Email & Phone Number

Bethesda, Maryland, United States

Bethesda, Md & Naval Support Activity Bethesda

*Subject matter expert for IRB protocol writing, editing, submission and approval processes originating from CPDR investigators and extramural collaborators within the DoD and DHA.*Apply IRB regulatory requirements of WRNMMC, USU, HJF, DoD, DHA, and collaborating military or civilian sites.*Implements and adheres to the standard operating procedures and policies set forth by each institution and adapts as IRB regulations and/or SOPs change over time.*Maintains knowledge on upcoming changes to the laws and regulations surrounding research.*Maintains/organizes electronic records of all IRB protocols. *Maintains/coordinates all required research training.*Performs necessary functions required for preparing publication clearance forms, data forms, and rosters.

Bethesda, Md

*All duties of the Regulatory Affairs Coordinator, plus • Administered and managed a multi-center, international Phase II clinical breast cancer trial between sponsors, sites, and data entry team. Duties included leading a data team to enter, clean-up and extract data from a MS database, organizing and maintaining all research and FDA records, IRB submissions for 2 DoD sites, program manager duties, and assisting Sponsor with FDA submission documents.• Interim Regulatory Specialist for the Center for Prostate Disease Research (CPDR) (6 months).• Managed a portfolio of over 250 active protocols, which included cancer, infectious diseases, and HIV.

Bethesda, Md

*All duties of the Regulatory Affairs Assistant, plus • Interim Regulatory Specialist for the Infectious Disease Clinical Research Program (IDCRP) at the Walter Reed National Military Medical Center (WRNMMC) (9 months).• Conducted site monitoring visits to ensure compliance with all regulations regarding human subjects’ protection. • Assisted in departmental training, sharing best practices, and instilling departmental standards for consistency. • Managed the department’s Tracking database, HJF Home Office regulatory guides, and HJF’s Guide to Services webpage.• Accessed documents organized under the RedCap system (EDC).• Managed a portfolio of over 250 active protocols, which included cancer, infectious diseases, HIV, wound healing, TBI, PTSD, Mental Health, cardiovascular, Sepsis, neurogenerative, and whole genome sequencing (WGS).

Rockville, Md

• Coordinated the review of grants, contracts, clinical trials, and other research related activities to ensure compliance with all regulations involving human subjects, laboratory animals and utilization of recombinant DNA and select agents. • Coordinated the submission of IRB/IACUC documents for secondary DoD review according to funding agreement.• Created, developed, and managed the departmental Tracking database.• Maintained regulatory files in accordance with GCP – periodic quality control and completeness checks for accuracy; final reconciliation and archiving of documents.• Assisted with internal/external audit preparation of files.• Attended project/study meetings and generated meeting minutes.• Managed a protocol portfolio of over 150 active protocols, which included infectious diseases, HIV, TBI, PTSD/TBI, Mental Health, cardiovascular, wound healing, neurodegenerative and amputee.

Gaithersburg, Md

*Front desk and overall office management including supervision *Human Resource duties including training/orientation, administration of all benefits and credit cards, updating personnel and training files *Overall management of new office location in California.*General knowledge of research and regulatory procedures/processes including clinical trials, IRBs, PIs, TMFs, AE/SAEs, contracts and proposals.

Sedona, Az

*Technical computer work including backups, installations, internet capabilities, troubleshooting, networking and training.*Organization and accuracy of forms and files, including electronic client records.*Data entry into FileMaker Pro database.*Transcription of clinical notes.*Management of administrative staff needs.

Broomall, Pa; Media, Pa; Swarthmore, Pa

*Processed bank transactions.*Reconciled teller cash and receipts, and assisted others with reconciliation.*Acting Head Teller duties on weekends.

Master Of Science Health Sciences, Regulatory Affairs

Summa cum laude

B.S., Business Administration

Activities and Societies: Student Government, Volleyball

Mathematics Major