Regulatory Coordinator

• Sep 2015 - Present

Responsible for regulatory start up and maintenance for pulmonary, critical care, neuroscience and infectious disease research studies. Liaison with Institutional Review Board. Managed IND applications to FDA, including protocol amendments, IND safety reports, and annual reports. Responsible for internal compliance audits and budget development. Developed databases and mentored junior staff. Developed internal audit tracking databases and training tools for other staff members. Advised principal investigators and study team members on Good Clinical Practices and federal regulations. Responsible for creation of clinicaltrials.gov records. Show less

Research Administration Program Manager

• Dec 2017 - Present

Clinical Research Regulatory Coordinator

• Oct 2010 - Present

• Obtained and maintained Institutional Review Board approval and managed regulatory aspects for 74 clinical research studies, including IND and IDE studies, post-approval studies, investigator-initiated research studies, and Humanitarian Use Device applications. • Completed Investigational New Drug applications to the FDA and assisted principal investigators with the initiation and documentation of IND trials. • Drafted protocols and consent forms and completed new study applications, protocol amendments, continuing review applications, and reports • Maintained the research record through careful documentation. • Advised principal investigators and study team members on regulatory issues and maintained IRB compliance and high standards of ethical conduct Show less

Regulatory Coordinator

• Sep 2014 - Aug 2015

Responsible for regulatory management of 120 oncology clinical trials. Responsible for IRB submissions and study documentation for sarcoma, melanoma, molecular imaging, GI, and hematology. Responsible for regulatory management of 120 oncology clinical trials. Responsible for IRB submissions and study documentation for sarcoma, melanoma, molecular imaging, GI, and hematology.

Study Coordinator

• Sep 2000 - Oct 2010

• Recruited and enrolled research participants, obtained informed consent, reviewed chart records, maintained databases, screened for patient safety, and scheduled exams • Drafted technical protocol summaries from grant applications. • Prepared Institutional Review Board submissions, wrote consent forms, and maintained IRB approval for fourteen studies. • Coordinated research studies measuring coronary artery calcium with computed tomography (CT). Tracked enrollment data, corresponded with physicians, and prepared reports for patients and physicians. • Presented a study co-authored with Dr. Hyo-Chun Yoon comparing multi-detector computed tomography and electron beam CT in the detection of coronary artery calcium at the Society for Interventional Radiology Conference in 2003. • Transferred research data from MRI scanner and maintained data storage on raid systems and on discs. • Maintained file organization on raid systems using UNIX. • Executed a Z-buffer segmentation algorithm in IDL to create three dimensional moving image files of the intracranial blood vessels for research applications and neurosurgery. • Operated software and performed study blinded measurements of myocardium tissue for cardiac perfusion studies. • Executed a segmentation algorithm to visualize mouse kidneys and imaging for other animal studies. • Edited and reviewed theses and publications for graduate students. • Completed IACUC applications. Show less