IRB Administrator - Human Subjects Protection Program

Company: Hartford HealthCare
Location: Hartford
Posted on: January 26, 2023

Job Description:

Description
Job Schedule: Full Time
Standard Hours: 40
Job Shift: Shift 1
Shift Details:

Work where every moment matters.

Every day, almost 30,000 Hartford HealthCare employees come to work with one thing in common: Pride in what we do, knowing every moment matters here. We invite you to become part of Connecticut's most comprehensive healthcare network.

Hartford Hospital is one of the largest and most respected teaching hospitals New England. We are a Level 1 Trauma Center that provides cutting edge treatment to its patients. This is made possible by being home to the largest robotic surgery center in the Northeast and the Center for Education, Simulation and Innovation (CESI), one of the most-advanced medical simulation training centers in the world. When hospitals cannot provide the advanced care, expertise and new treatment options their patients require, they turn to us.Job Summary:This position coordinates and performs a full range of administrative functions in support of the Hartford HealthCare System-wide Human Research Protection Program (HRPP), Institutional Review Board (IRB), and Institutional Animal Care and Use Committee (IACUC), acting in an independent manner in making office decisions and managing study workflow. This position supports the IRB Chairs and Members and other Research Administration leadership for both the IRB and the HRPP. Primary duties include, conducting preliminary review of all research protocols for compliance with standard requirements outlined in office policies and state and federal regulations, communicating directly with principal investigators to resolve issues, assigning protocols to an appropriate level of review, preparing for and attending committee meetings and taking minutes at the meeting in accordance with federal regulatory requirements. Additionally, the IRB Administrator prepares detailed correspondence to principal investigators to communicate findings of the IRB or IACUC, i.e. study approval letters, study termination letters, study continuation reminders, modification letters, and miscellaneous correspondence as necessary, and provides researchers with assistance responding to IRB/IACUC actions and revision requests. Reports to IRB Manager.

Qualifications

• Bachelor's degree in science field, education, public administration, management, or related field required. Advanced degree preferred. Certified IRB Professional (CIP) or other research professional organization certification (i.e., SoCRA CCRP or ACRP CCRC) preferred.
• Minimum of five years relevant professional experience. Experience working with Institutional Review Boards or human subject's protection programs or direct experience in a research setting preferred.
• IRB experience in both biomedical research and research in the social and behavioral sciences in either a large healthcare system or in an academic medical center.
• Experience with electronic IRB systems
• Demonstrates comprehensive knowledge and understanding of management and administrative principles and practices; an ability to work with committees, manage multiple complex administrative tasks, and prioritize responsibilities.
• Basic working knowledge of biological principles and scientific methods and basic working knowledge and experience in federal regulations governing human subject research and federal reporting requirements (OHRP, FDA, HIPAA, ICH GCPs, etc.) and AAHRPP accreditation standards.
• Demonstrated ability to exercise good judgement in areas of ambiguity, discretionary and confidential information and exemplifies high standards of professionalism, responsibility, accountability, and ethical behavior.
• Ability to function independently and proficiently with minimal oversight drawing upon excellent time management and prioritization skills
• Demonstrates exceptional writing and verbal presentation skills.
• Communicates effectively with researchers, faculty, and other research personnel, management, the HRPP/IRB staff, and the general public.
• Ability to hold self-accountable for quality outcomes and continuous quality improvement.
• Assists the IRB Manager in maintaining the effectiveness and efficiency of the QI Program internal Quality Assurance audits by conducting and documents periodic internal/self-assessment audits of the IRB program, including an evaluation of written policies, procedures, databases, electronic file records, and overall efficiency.
  
  We take great care of careers.
  
  With locations around the state, Hartford HealthCare offers exciting opportunities for career development and growth. Here, you are part of an organization on the cutting edge - helping to bring new technologies, breakthrough treatments and community education to countless men, women and children. We know that a thriving organization starts with thriving employees- we provide a competitive benefits program designed to ensure work/life balance. Every moment matters. And this is your moment.

Keywords: Hartford HealthCare, Hartford , IRB Administrator - Human Subjects Protection Program, Other , Hartford, Connecticut