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									                                         Rikki Eccles
                                        11801 York St.
                                          Apt # 1515
                                    Thornton, CO 80233

Experienced Regulatory and Compliance Professional. Areas of expertise include:
   • Oncology
   • Clinical Research including GCP, FDA regulations
   • Writing
   • Review/Editing
   • Analysis
   • Protocols
   • Reports

OBJECTIVE : To obtain a position within a reputable and established company.

Bachelor of Science, December 2005
Regis University, Denver, CO.
Major: Biology
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

Clinical Trials Specialist, Apria Healthcare-Coram Clinical Trials, Denver, CO July 2009-
November 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
       Review Board
   ● 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

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