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.

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.
• 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).

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.
• 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.

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.

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