Identified, advised, and instrumental in identifying and implenteing the need for a web based program for regulatory and audit purposes.
Assessed the need and implemented organizational training needs for new program.
Company NameCity, StateIRB Regulatory Specialist
Responsible for performing all operational duties of the Institutional Review Board (IRB) and plays an integral role in the review of human subject research.
Each research study that is submitted is thoroughly screened to ensure information accuracy and completeness and is sufficient for determination by the proper board.
This requires the ability to comprehend and problem solve within the framework of federal regulations, laws and guidance pertaining to human subject protection which includes the Common Rule, FDA regulations, HIPAA regulations, Good Clinical Practice, the Declaration of Helsinki, Belmont Report as well as Mercy Hospital Policy and Procedures.
Attend committee meetings to document the committee's meeting actions, deliberations on regulatory and ethical issues and changes to the research plan determined by the committee to be necessary to secure approval.
Communicates the committee's requirements to the research team and works with the research team in resolving any required actions.
Educate new researchers of the IRB submission process and what is necessary to complete new study submissions.
Company NameCity, StateMedical Secretary
Louis-Cape Girardeau Community Clinical Oncology (CCOP) Program at St.
Worked directly in support of the CCOP Principal Investigator, the CCOP IRB Chairman and the Clinical Research Coordinators.
Assisted the Principal Investigator with complex grant proposals, progress reports and budget reports.
Was responsible for all IRB material for meetings and maintaining IRB files for audit purposes.
Attended the IRB meetings to document committee's meeting actions, deliberations on regulatory and ethical issues and changes in the research plan determined by the committee to be necessary to secure approval.
Communicated to the research team the committee's response in resolving actions by the committee to secure approval.
Company NameCity, StateUnit Secretary
Scheduled medical tests, transcribed doctor's orders, answered telephones, filed reports, answer patient call lights in the Nursery and Postpartum departments, Cardiac Care Unit and Medical Surgical Floors of the hospital.
Medical Transcription, self employed.
Self employed as a medical transcriptionist for a busy internist office in Paducah, Kentucky.
On a daily basis I went to the main office of a busy internist office to pick up tapes to transcribe and delivered the tapes and printed information the next day.
Company NameCity, StateMedical Secretary
Answered phones, scheduled patient appointments, patient billing, pre-certification and referrals for insurance companies for various patient tests and procedures, filed reports, set up physician appointments and transcribed medical dictation for a very busy gastroenterologist office.
Company NameCity, StatePediatric Neurology Secretary
Responsible for patient scheduling and other clinic related duties, reports, arranging and scheduling meetings and travel arrangements for the Director of Neurology, transcription of letters and patient notes, responsible for typing manuscripts and other publication material, answering the telephone and maintaining files in a very busy office setting.
Education and Training
Maryville UniversityCity, StateBachelor of Science: Business AdministrationBusiness Administration
St. Louis Community College at MeramecCity, StateAssociate Degree: Arts and SciencesArts and Sciences
Missouri Baptist Nursing SchoolCity, StateCompleted one year of a two year R.N. nursing program
PRIM&R (Public Responsibility in Medicine and Research) since 2005 NAIL (National Association of IRB Leaders) 2007-2014 certification PRIM&R (Public Responsibility in Medicine and Research) since 2012 PREseNTATIONS Malone, I, Bird P. "Incidental Findings and the Role of the IRB", National Association of IRB Leaders, Atlanta, Georgia, May 2014.
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St. Louis Community College at Meramec
Missouri Baptist Nursing School
Job Titles Held:
IRB Regulatory Specialist
Pediatric Neurology Secretary
Bachelor of Science : Business Administration Associate Degree : Arts and Sciences
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