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Jessica Claire
  • Montgomery Street, San Francisco, CA 94105
  • H: (555) 432-1000
  • C:
  • resumesample@example.com
  • Date of Birth:
  • India:
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Professional Overview

Experienced Institutional Review Board Professional with areas of competence in Biomedical and Social-Behavioral research with additional skills in public health education and promotion

Core Qualifications
  • Microsoft Suite
  • FDA/HHS Human Subjects Research Regulations
  • Public Health Education and Promotion
  • Biomedical/Clinical Trial Research



  • Research Curriculum and Training
  • Program Development
  • Goal Setting and Implementation
  • Academic Research Protocol Writing
Accomplishments
  • Worked directly with Director of Research Compliance to successfully manage the process of protocol reviews and approvals.
  • Collaborated with research department and faculty members to design an annual workshop and training
  • Served on the Institutional Review Board at CDH and DePaul
  • Introduced a more effective way to provide IRB members with Full Board review materials
  • Worked directly with the Associate Medical Director for Primary Care to develop a site-wide self-management health goal form
Education
MPH: Public Health, Expected in 2014
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Benedictine University - Lisle, IL
GPA:
Bachelor of Science: Biology/Chemistry, Expected in 2003
-
University of New Mexcio - Albuquerque, NM
GPA:
Thesis/Dissertation

MPH Focus: "Health Literacy Education and Promotion in Community Health Clinics" examines the impact of low health literacy in patient quality of care and self-management. Questions how health literacy education and promotion can effectively improve health.

Experience
Assistant Director of Research Compliance, 2012 - 10/2014
University Of Florida Gainesville, FL,
  • Assisted with the day to day operations of the human subject protection program at DePaul and with the operations of the Animal Care and Use Committee (IACUC) and Institutional Biosafety Committee (IBC).
  • Served as an aid in ensuring that DePaul remains compliant with institutional policy and federal, state, and local rules and regulations, and ethical principles pertaining to the Institutional Review Board (IRB), IACUC, and IBC.
  • Monitored and coordinates procedural activities within the overall scope of federal regulations concerning human subjects, conflict of interest and scientific misconduct.
  • Worked independently on duties related to the IRB review process; coordinate IRB submissions, facilitate the review process, conduct reviews, and corresponds with investigators, faculty and students.
  • Served as an aid in implementing an on-line information system and electronic submission system.
  • Responsible for writing and assisting with implementation of new policies, procedures and revisions to forms
  • Maintained the human subject research Access databases (track IRB submissions and approvals and human subjects training (CITI))
  • Developed and conducted investigator and IRB education sessions
  • Provided assistance with IACUC and IBC administrative duties
  • Responsible for the development and presentation of the annual IRB/LRB Protocol Workshop and Education
  • Responsible for the orientation and training of IRB members regarding DePaul policies and procedures and any federal regulations concerning human subjects protection.
  • Mentored Research Protections Coordinator I in policies and procedures directly related to human subjects research regulations and guidance.
IRB Officer, 10/2008 - 08/2011
Amedisys Home Health Services Sioux Falls, SD,
  • Provided central support to the IRB members, Principal Investigators, and Hospital Administration concerning Federal, State and Hospital regulations and guidelines
  • Monitored and coordinated procedural activities within the overall scope of federal regulations concerning human subjects, conflict of interest and scientific misconduct
  • Served as a primary liaison and support to IRB members and Principal Investigators, government official institutions and Clinical Research Coordinators Served as a lead IRB officer during a current Central DuPage Hospital IRB FDA inspection.
  • Responsible for the day-to-day operation of the IRB office including IRB meetings, ensures accurate documentation of final committee decisions and provides communication between the IRB and researchers
  • Prepared IRB meeting agendas and materials
  • Responsible for the development and maintenance of human subject research databases (protocol databases to track IRB submissions, review and termination dates, and adverse event reporting), membership databases (appointment letters, roster and curriculum vitae files)
  • Established files for new IRB submissions, manages the compilation and archiving of appropriate records and documentation on all IRB submissions
  • Assisted in the development of an electronic submission system
  • Responsible for the implementation of orientation and training for staff, IRB members, and Principal Investigators regarding policies, procedures and regulations concerning human subjects protection
  • Responsible for identifying any new and revised government regulations regarding conduct of human subjects research and for distributing the information to the Office of Research Support, IRB Members, investigators, coordinators and the Central DuPage Hospital Research community.
  • Participated in department-based Quality Assurance Program (patients on study drug)
Regulatory Coordinator, 02/2008 - 10/2008
Harvard University Boston, MA,
  • Organized the regulatory affairs activities to promote clinical research and ensure compliance with regulatory (FDA) guidelines
  • Prepared regulatory documents (annual reviews, protocol violations, safety reports, amendments, etc) and IRB submissions for all protocols
  • Tracked status of pending protocols for IRB review
  • Oversaw preparation of all closed study files for archiving in long term storage, and maintains archived documents on and off site
  • Maintained and set up regulatory files for CRA monitoring visits
  • Responsible for maintenance of current and historical copies of laboratory accreditations, reference ranges, Principal Investigator and research staff CVs, and medical licenses
  • Assisted the Clinical Research Coordinators with development of working folders for study enrollment as needed
  • Retrieval of critical regulatory documents and signatures from investigators (FDA 1572, protocol signature page, financial disclosure)
  • Assisted with preparation for monthly Research Committee Meetings.
Research Project Coordinator, 02/2005 - 02/2008
Northwestern University City, STATE,
  • Recruited research subjects via phone and mail for the Department of Rheumatology research studies, including patients and healthy volunteers
  • Worked directly with Northwestern Memorial Hospital Departments and Medical Staff to achieve research study site visits for patients and health volunteers.
  • Obtained proper paperwork and research documentation such as informed consent, SF-36, and additional questionnaires.
  • Organized all scheduling of study participants for follow up and initial visits
  • Coordinating initial and follow up study visits for the patients and healthy controls
  • Collected study data, maintaining database and preparing study visit reports as required
  • Assisted in submittal process of required documents for research proposals such as IRB protocols
  • Maintained communication with the study participants by conducting follow up interviews
  • Obtained information from various physicians/hospitals regarding participant fractures and cardiovascular events
  • Maintained databases for blood collection, shipping, and receiving for all participants.
Internship Experience

Cook County Hospital and Health System, Chicago, IL - Ambulatory and Community Health Network (ACHN): Health Literacy and Self-Management

Preceptor:

Dr. Anne Jacobson, MPH

ACHN Associate Medical Director for Primary Care

Lead Physician, Cicero Health Center of Cook County

Certifications

CITI Program for the Protection of Human Research Subjects certified

Health Education and Promotion Certified (December 2014)

Skills

research compliance; research protocol management; public health development; quality assurance/improvement

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School Attended

  • Benedictine University
  • University of New Mexcio

Job Titles Held:

  • Assistant Director of Research Compliance
  • IRB Officer
  • Regulatory Coordinator
  • Research Project Coordinator

Degrees

  • MPH
  • Bachelor of Science

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