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irb analyst ii resume example with 20+ years of experience

Jessica Claire
  • , , 609 Johnson Ave., 49204, Tulsa, OK 100 Montgomery St. 10th Floor
  • Home: (555) 432-1000
  • Cell:
  • resumesample@example.com
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Summary
  • Master’s Degree in Business Administration and thirty-two years’ professional experience in clinical, laboratory, and animal research, with seven years’ management experience in research administration.
  • Manager of the Ochsner Office of Research Support for 7 years with a staff of 5 supervisors and 50 research coordinators deployed to 27 clinical departments on several campuses. Oversight included personnel productivity, performance and professional development.
  • Ten years’ experience on LSUHSC-NO’s IRB. Voting Board member, Senior Analyst and expert in Federal and Institutional Regulation compliance. Coordinates all full board IRB study reviews, meeting agendas, and notes to ensure compliance with federal guidelines, assure efficiency, and effectiveness of monthly IRB meetings. Extensive experience in all types of IRB reviews, approvals and research compliance.
  • LSUHSC-NO IRB regulatory expert and consultant for Emergency Use and Expanded Access usage of drugs and devices and Humanitarian Use Devices by our physicians for the treatment of life-threatening diseases and conditions Analytical professional with technical knowledge and critical thinking skills to thrive in data-driven environments.
Skills
  • Microsoft Office Suite
  • Presentation Development and Delivery
  • Kuali IRB electronic submission system
  • Team Collaboration and Leadership
  • Regulatory Compliance
  • Excellent communication
  • Process Improvement
  • Policy Interpretation
Experience
IRB Analyst II, 10/2013 to Current
Hdr, Inc.Englewood, CO,
  • Coordinates all Full Board meeting reviews, agendas, minutes and administrative tasks prior to each meeting to ensure compliance with federal guidelines and to assure efficient and effective conduct of meetings.
  • Lead internal IRB regulatory expert and consultant for Emergency Use and Expanded Access usage of drugs and devices and Humanitarian Use of Devices by our physicians for the treatment of life-threatening diseases and conditions.
  • Liaison for reporting of all serious or continuing instances of non-compliance, unanticipated events, and study suspensions to the Office of Human Research protections and other agencies as required by the federal regulations.
  • Experienced in all of the following types of IRB reviews and approvals: Non-human Subject Research Determinations, Exempt, Expedited, Full Boards, Reportable New Information, Expanded Access, Humanitarian Use Device and Post-Approval submissions
  • Assists/advises stakeholders with IRB regulatory guidance.
  • Identifies educational needs of stakeholders, develops educational materials and provides presentations and/or information related to federal regulations, IRB policies and procedures, and Good Clinical Practices to a variety of institutional stakeholders. Thus, assuring compliance with institutional research to existing regulatory and institutional policy requirements
  • Conducts workplace staff compliance training to reduce liability risks and increase patient safety.
  • Participates in regular meetings with management to assess and address issues and identify and implement improvements.
  • Contributes to an on-going assessment of all policies, procedures and documentation and is instrumental in the creation and maintenance of policies and procedures for the IRB, its administrative staff and researchers.
  • Aided in the development and successful implementation of Kuali electronic IRB system.
  • Aided with the AAHRPP re-accreditation process.
  • Works with the Institutional Review Board and Institutional Biosafety Committee to ensure protocol approvals.
Director of Clinical Research Support, 09/2006 to 09/2013
First Financial BanksharesMerkel, TX,
  • Spearheaded the consolidation and centralization of a clinical research coordinator workforce for more effective and efficient support of Ochsner investigators
  • Oversight of daily activities of five supervisors and up to 50 coordinators facilitating research in 27 clinical disciplines while supporting approximately 200 physicians and 300-400 clinical trials annually.
  • Responsible for managing $11.5M budget.
  • Instrumental in the annual growth rate of 20% in the number of clinical trials over the past five years, as well as an increase in the number of new research participants
  • Participated in regular meetings with management to assess and address issues and identify and implement improvements.
  • Conducted detailed analysis on key trends and findings to summarize findings for leadership.
  • Responsible for strategic planning, development and overall accountability for the Clinical Research Support Department.
  • Streamlined the process for approval of Confidentiality Disclosure Agreements, reducing the length of process to 7-day average.
  • Developed and delivered ongoing research educational program.
  • Responsible for research regulatory compliance, and the training and development of the research staff and investigators to that end.
  • Served as a resource for investigators, scientists and coordinators in matters related to governmental regulations and Good Clinical Practice.
Senior Administrative Project Coordinator, 08/2003 to 08/2006
Ochsner Health System-Academic DivisionCity, STATE,
  • Planned, developed and managed the staffing and conduct of clinical trials with available central resources.
  • Maintained relationships with diverse stakeholders and clinical team members through regular meetings to communicate needs assessment.
  • Managed associated administrative activities of Clinical Research Department
Research Specialist, 01/1991 to 01/2023
Tulane University Health Sciences CenterCity, STATE,
  • Managed multiple industry sponsored clinical trials and served as the principle liaison between physicians, medical school, hospital/clinic personnel, patients and sponsors.
  • Ensured compliance to all FDA, sponsor and institutional rules and guidelines for research conduct.
  • Negotiated and prepared all clinical trial budgets for the department.
  • Responsible for drug formulation and safety testing, drug dosing and administration of drug to human subjects in investigator initiated trails for Endocrine Department.
  • Preparation, performance and completion of research experiments, both animal and tissue.
  • Coordination of all aspects of investigator initiated research trials.
  • Analyzed laboratory findings to confirm accuracy of results.
  • Collected and analyzed data to contribute to manuscripts and publications.
  • Operated and calibrated equipment in multiple and diverse laboratory environments.
  • Obtained data from patient medical records, histories and surveys.
Education and Training
MBA: Magna Cum Laude, Expected in 12/2010 to University of New Orleans - New Orleans, LA
GPA:
Bachelor of Science: Medical Technology, Expected in 12/1973 to Louisiana State University School of Allied Health - New Orleans, LA,
GPA:
Activities and Honors

PROFESSIONAL AFFILIATIONS

•Association of Clinical Research Professionals, 2001

Honored 12 year Membership

•Public Responsibility in Medicine and Research (PRIM&R), 2013 to present

RECOGNITIONS

•Beta Gamma Sigma Honor Society

Membership 2010 to present

MBA-

(Graduated Magna cum Laude) GPA 4.00

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Resume Overview

School Attended

  • University of New Orleans
  • Louisiana State University School of Allied Health

Job Titles Held:

  • IRB Analyst II
  • Director of Clinical Research Support
  • Senior Administrative Project Coordinator
  • Research Specialist

Degrees

  • MBA
  • Bachelor of Science

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