SUMMARY
Analytical and detail-oriented professional with ability to gather and analyze information. Effective working independently and in team environments.
EDUCATION
Texas A&M University, College Station, TX
Bachelor of Science in Biomedical Sciences
PROFESSIONAL EXPERIENCE
Health Integrity, LLC Houston, TX
Investigator June 2012 - October 2016
Searched computer databases, public records, and other sources to locate Medicare beneficiaries and compile information for investigations.
Identified and summarized information into written investigative reports.
Conducted detailed investigative research on individuals and healthcare providers.
Performed phone and in-person interviews of complainants, witnesses, and subjects of investigations.
Houston Methodist Hospital Houston, TX
Regulatory Compliance Specialist II September 2008 - May 2012
Collaborated with the IRB, FDA, and investigators to ensure protocol approval in a timely fashion.
Performed regulatory and safety reporting for studies in accordance with regulations and procedures.
Prepared research protocols, amendments, renewals, and safety reports for IRB submission.
Maintained files for all studies to ensure regulatory compliance.
Worked closely with study sponsor and study personnel on relevant regulatory safety issues.
Organized documentation in preparation for external and internal audits.
Baylor College of Medicine Houston, TX
Regulatory Affairs Coordinator July 2007 - August 2008
Prepared clinical trial submissions for review (initial and continuing reviews, and protocol amendments) by appropriate regulatory agencies, including the IRB, FDA, RAC, and IBC.
Maintained protocol regulatory files to ensure all records were up-to- date, accurate, and compliant with federal and institutional regulations.
Notified investigators and study staff of protocol updates and distributed current protocols and consent forms.
Assisted with data collection and reporting of Serious Adverse Events to appropriate regulatory agencies and sponsors.
Prepared regulatory reports and coordinated data collection with other departments.
SKILLS
MS Word, Excel, PowerPoint, Outlook
Analytical and detail-oriented professional with ability to gather and analyze information. Effective working independently and in team environments.
EDUCATION
Texas A&M University, College Station, TX
Bachelor of Science in Biomedical Sciences
PROFESSIONAL EXPERIENCE
Health Integrity, LLC Houston, TX
Investigator June 2012 - October 2016
Searched computer databases, public records, and other sources to locate Medicare beneficiaries and compile information for investigations.
Identified and summarized information into written investigative reports.
Conducted detailed investigative research on individuals and healthcare providers.
Performed phone and in-person interviews of complainants, witnesses, and subjects of investigations.
Houston Methodist Hospital Houston, TX
Regulatory Compliance Specialist II September 2008 - May 2012
Collaborated with the IRB, FDA, and investigators to ensure protocol approval in a timely fashion.
Performed regulatory and safety reporting for studies in accordance with regulations and procedures.
Prepared research protocols, amendments, renewals, and safety reports for IRB submission.
Maintained files for all studies to ensure regulatory compliance.
Worked closely with study sponsor and study personnel on relevant regulatory safety issues.
Organized documentation in preparation for external and internal audits.
Baylor College of Medicine Houston, TX
Regulatory Affairs Coordinator July 2007 - August 2008
Prepared clinical trial submissions for review (initial and continuing reviews, and protocol amendments) by appropriate regulatory agencies, including the IRB, FDA, RAC, and IBC.
Maintained protocol regulatory files to ensure all records were up-to- date, accurate, and compliant with federal and institutional regulations.
Notified investigators and study staff of protocol updates and distributed current protocols and consent forms.
Assisted with data collection and reporting of Serious Adverse Events to appropriate regulatory agencies and sponsors.
Prepared regulatory reports and coordinated data collection with other departments.
SKILLS
MS Word, Excel, PowerPoint, Outlook