Assistant Director Of Research Compliance Resume Example Company Name

ASSISTANT DIRECTOR OF RESEARCH COMPLIANCE

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

Benedictine University2014MPH: Public HealthCity, State, USA

University of New Mexcio2003Bachelor of Science: Biology/ChemistryCity, State, USA

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

Company NameJanuary 2012 to November 2014Assistant Director of Research Compliance
City, State

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.

Company NameNovember 2008 to September 2011IRB Officer
City, State

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)

Company NameMarch 2008 to November 2008Regulatory Coordinator
City, State

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.

Company NameMarch 2005 to March 2008Research Project Coordinator
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

Resume Overview

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 : Public Health
Bachelor of Science : Biology/Chemistry

Assistant Director of Research Compliance Resume Example

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