11801 York St.
Apt # 1515
Thornton, CO 80233
Experienced Regulatory and Compliance Professional. Areas of expertise include:
• Clinical Research including GCP, FDA regulations
OBJECTIVE : To obtain a position within a reputable and established company.
Bachelor of Science, December 2005
Regis University, Denver, CO.
Relevant Coursework: Biology, Chemistry, Microbiology, Physics.
Certified Clinical Research Professional (CCRP) through Society of Clinical Research Associates
Graduate of NAPSRTM’s Pharmacology/Pharmaceutical Sales Training Program.
CNPR # 552392006
Senior Compliance Analyst, DaVita, Inc., Denver, CO November 2009-July 2010
● Lead Investigator on internal HIPAA and Security Breach investigations
● Created and implemented process for HITECH regulations
● Create and implement policies and procedures
● Provide metrics and follow up on IT, Security breach and stolen/lost media
● Monitor dialysis facilities for compliance to DaVita policies and procedures
● Conduct re-education and training for teammates when necessary
● Design and maintain monthly regulatory update newsletter for senior VP’s
● Review and update compliance policies and procedures
● Obtain and execute Business Associate Agreements
● Employee Training and education
● Lead Auditor on stolen/lost media and email encryption
● Designed and implemented webpage for Vendors on DaVita.com
CLINICAL RESEARCH EXPERIENCE
Clinical Trials Specialist, Apria Healthcare-Coram Clinical Trials, Denver, CO July 2009-
● Monitor homecare agencies for compliance to research protocols and FDA regulations
● Coordinate field and in-house activities for specific studies
● Review documentation for completeness and accuracy
● Function as a liaison between sponsor, study investigator, CRO and other study personnel
● Assist in developing study support information (training manuals and proposals)
● Provide information to field clinical trial personnel to facilitate successful implementation,
monitoring and evaluation of studies
● Review, verify and approve invoices for study-related services
● Prepare trip and expense reports; detail activities, issues, problems, etc., for each monitoring
● Complete other duties as assigned by Director
Regulatory Affairs Coordinator, University of Colorado-Clinical Investigations Core, Aurora, CO
May 2006-June 2009
● Developed knowledge of Good Clinical Practices Manual, FDA Rules and Regulations in
relation to clinical trials, NIH guidelines and HIPAA regulations in relation to clinical trials.
● Developed an understanding of the phases and concepts of clinical trials and the overall
philosophies of conducting cooperative group research.
● Served as regulatory contact person for ongoing clinical research in BMT, Hematological
Malignancies and Thoracic Oncology.
● Submitted complete and accurate clinical research applications to all required regulatory
● Wrote subject informed consent documents and HIPAA Authorizations.
● Completed continuing review of research as directed by the Colorado Multiple Institutional
● Prepared and submitted amendments and revisions from sponsors and investigators.
Professional Research Assistant, University of Colorado-Clinical Investigations Core, Aurora, CO
August 2005-May 2006
● Maintained financial and regulatory databases.
● Paid patients and hospital bills.
● Reviewed subject informed consent forms.
● Responsible for all safety update tracking and submission to the IRB.
● Wrote protocol summaries for various disease sites.
● Society of Clinical Research Associates (SoCRA)
● Member of the National Association of Pharmaceutical Sales Representatives (NAPSR)
● Education Committee Member, Clinical Investigations Core
● Policy Committee Member, Clinical Investigations Core
Readily Available Upon Request