irb regulatory specialist resume example with 20+ years of experience
JessicaClaire
Montgomery Street, San Francisco, CA94105609 Johnson Ave., 49204, Tulsa, OK
Home: (555) 432-1000
Cell:
resumesample@example.com
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Professional Background
Highly motivated Sales Associate with extensive customer service and sales experience. Outgoing sales professional with track record of driving increased sales, improving buying experience and elevating company profile with target market.
Skill Highlights
Guest services
Inventory control procedures
Merchandising expertise
Loss prevention
Cash register operations
Product promotions
Accomplishments
Process Improvement
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.
Professional Experience
IRB Regulatory Specialist, 01/2005 to Present Excela Health – Latrobe, PA,
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.
Medical Secretary, 01/1998 to 01/2006 Vidant Health – Kinston, NC,
St.
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.
Unit Secretary, to Excela Health – Mount Pleasant, PA,
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.
Medical Secretary, to Bo-Linn, Benage, And Associates, Inc – City, STATE,
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.
Pediatric Neurology Secretary, to Cardinal Glennon Children's Hospital – City, STATE,
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
Bachelor of Science: Business Administration, Expected in 2004 to Maryville University - St. Louis, Missouri GPA: Business Administration
Associate Degree: Arts and Sciences, Expected in 1983 to St. Louis Community College at Meramec - St. Louis, Missouri GPA: Arts and Sciences
: , Expected in to Missouri Baptist Nursing School - St. Louis, Missouri GPA: Completed one year of a two year R.N. nursing program
Certifications
,
Affiliations
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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