Overview

Job Description Location:Hollywood, Florida At Memorial, we are dedicated to improving the health, well-being and, most of all, quality of life for the people entrusted to our care. An unwavering commitment to our service vision is what makes the difference. It is the foundation of The Memorial Experience. Summary: Coordinates the day-to-day activities of the Institutional Review Board (IRB) office, including review of research protocols for regulatory compliance, protocol review management, and assistance with the meetings of the Board. Reviews submitted applications, makes the final compliance determinations and approval decisions. Responsibilities: Assists and performs additional tasks related to day-to-day operations of the IRB office as assigned by the IRB Director. Serves as the alternate voting member for the IRB Director and moderates IRB meetings, as needed. Drafts and distributes agenda and materials to the IRB members ahead of meetings along with official meeting minutes after the meeting. Summarizes any controverted issues, their resolution and the Board s action. Generates IRB correspondence related to action items and outcomes on each submission. Serves as a subject matter expert and maintains up-to-date knowledge on Department of Health and Human Services (DHHS) and Food and Drug Administration (FDA) regulations related to protections of human subjects in research. Assists the IRB Director with revisions to institutional policies and procedures. Maintains advanced knowledge of the electronic IRB submission system and future upgrades. Assists with the system set up and revisions of application forms and templates. Conducts reviews of complex scientific research protocols to ensure compliance with DHHS and FDA regulations. Determines applicable review types, identifies regulatory and ethical issues and facilitates revisions to the submissions. Makes final outcome determinations for submissions and communicates them to the IRB Director, Board Members, and study staff. Competencies: ACCOUNTABILITY, ACCURACY, ANALYSIS AND DECISION MAKING, CUSTOMER SERVICE, MANAGING PEOPLE, PROBLEM SOLVING, RESPONDING TO CHANGE, STANDARDS OF BEHAVIOR Education and Certification Requirements: Masters (Required)Certified IRB Professional (CIP) - Collaborative Institutional Training Initiative (CITI) Additional Job Information: Complexity of Work: This role requires critical thinking skills, effective communication, decisive judgment, and the ability to build and foster positive relationships. The incumbent must be able to lead others and take appropriate action when required.Required Work Experience: Five (5) years of experience working in an IRB office or as a reviewer of human subject research for regulatory compliance.Other Information: Additional Education Info: Master's degreed in a research or science related field.Additional Credential Info: Certified IRB Professional (CIP) required at time of hire. Working Conditions and Physical Requirements: Asbestos = 0% Audible Speech = 80% Bending and Stooping = 0% Bio hazardous Waste = 0% Biological Hazards - Respiratory = 0% Biological Hazards - Skin or Ingestion = 0% Blood and/or Bodily Fluids = 0% Climbing = 0% Communicable Diseases and/or Pathogens = 0% Computer Monitor = 80% Cytotoxic Chemicals = 0% Depth Perception = 80% Distinguish Color = 80% Domestic Animals = 0% Dust = 0% Extreme Heat/Cold = 0% Fire Risk = 0% Gas/Vapors/Fumes = 0% Hazardous Chemicals = 0% Hazardous Medication = 0% Hazardous Noise = 0% Hearing Acuity = 80% Heating Devices = 0% Hypoxia = 0% Keyboard Entry = 80% Kneeling = 0% Laser/High Intensity Lights = 0% Latex = 0% Lifting or Carrying > 75 lbs Non-Patient = 0% Lifting or Carrying 0 - 25 lbs Non-Patient = 0% Lifting or Carrying 25.01 lbs - 75 lbs Non-Patient = 0% Lifting/Carrying Patients 35 Pounds or Greater = 0% Magnetic Fields = 0% Moving Mechanical Parts = 0% Needles/Sharp Objects = 0% Potential Electric Shock = 0% Potential for Physical Assault = 0% Pushing