Institutional Review Board

2 weeks ago

Springfield, United States Oregon Research Institute Full time

IRB Administrator - Half-time (20 hours/week)

This position is open until filled. First review of applications begins August 19, 2024.

ORI employees work in a hybrid in-office/remote-work environment. The IRB Administrator may be required to work in the office a certain number of days per week, to be determined. For the right candidate, fully-remote work will be considered.

Purpose

Oregon Research Institute (ORI) is seeking an IRB Administrator to manage all functions supporting the protection of human research subjects.

ORI is an independent behavioral sciences research center dedicated to understanding human behavior and improving the quality of human life through the prevention and treatment of health, educational, and social problems. Our work is broad in scope, from basic research to understand the causes of human behavior, to developing programs to promote behavior change.

As a member of the administrative support staff to the Institute, the IRB Administrator will report to and collaborate with the Director of Finance and Administration (DFA) for planning, managing, and carrying out the effective delivery of IRB management services in support of ORI's mission and goals.

We actively seek employees from diverse communities and backgrounds and offer a collaborative, flexible and supportive environment where contributions are rewarded and recognized. We offer an opportunity to engage in projects that use science to transform people's lives. We offer competitive, equitable wages and a full benefit package including medical, dental, life and disability insurance; 403(b) retirement plan with generous match; as well as paid vacation, holiday and sick time.

Examples of Duties

  • Responsible for ensuring that the institute remains in compliance with federal, state, and local regulations governing human research subjects protection.
  • Initiates review of institutional policies and procedures as needed.
  • Provides guidance and advice to all key research personnel in the area of human research subjects protection.
  • Advises research personnel in preparing research protocols and subsequent submissions for IRB review.
  • Pre-reviews all types of research protocol submissions, including consent documents and advertisements for subject recruitment, to ensure that individual research protocols involving human subjects are in compliance with federal regulations and guidelines, state laws, and ORI policies and procedures for conducting research. This may require interaction with federal agency representatives, including the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA).
  • Regularly interacts and consults with the IRB membership, various outside institutional regulatory offices, federal and state agencies, and research personnel on the ethical, regulatory, and current issues in human subjects protection.
  • Assumes responsibility for continuing development, improvement, and delivery of education and training for research personnel on the protection of human research subjects.
  • Acts as primary liaison between the federal agencies that monitor compliance with the federal regulations governing protection of human research subjects (OHRP and FDA) and ORI.
  • Stays current with federal, state, and local policy and guideline changes and interprets those changes for research personnel.
  • Responsible for oversight of all IRB data, record keeping, and documentation of protocol reviews.
  • Oversees the continuing review of approved protocols and manages a protocol tracking system.
  • Responsible for maintaining the membership of the IRB, including education and training of IRB members.
  • Attends the IRB meeting as an ex officio member.
  • Develops monthly IRB meeting agenda and oversees the preparation of the meeting packet and minutes.
  • Provides guidance and coordinates with the ORI Grants Team and researchers during the lifecycle of a grant proposal. Responsible for ensuring accurate & timely submission of the human subjects sections of annual and final reports to the funder.
  • Responsible for compliance with NIH's requirements for registering & reporting NIH-funded Clinical Trials on ClinicalTrials.gov Serves as Administrator for ad hoc Data Safety & Monitoring Boards.
  • Responsible for all aspects of Single IRB Reliance agreements among institutions, whether as the Relying or Reviewing IRB.

Qualifications

  • Knowledge Skills and Abilities:
    • Knowledge of federal regulations and guidelines that govern the conduct of research involving human subjects.
    • Excellent oral and written communication skills, including strong public speaking skills.
    • Ability to organize, prioritize, and work under pressure to meet deadlines.
    • Ability to work independently, with minimal supervision.
    • Ability to work skillfully and cooperatively with research staff and IRB members.
    • Knowledge of Windows environment required.
    • Proficiency with word processing, database, and spreadsheet software required.
  • Experience and Training:
    • This position requires a Bachelor's Degree and five (5) years experience managing regulatory compliance issues for the protection of human subjects, or any equivalent combination of education and experience that provides the applicant with the knowledge, skills, and ability to perform the job.
    • Within three months of hire, the IRB Administrator is required to obtain a Certified IRB Professional (CIP®) certificate.
    • Demonstrated experience in successfully working with diverse groups of people.
    • Demonstrated experience in assuming responsibility for a department or major administrative function and in organizing and overseeing complex tasks through to completion.
    • Familiarity with funding agency policies and procedures on the conduct and reporting of human subjects research is desirable.
    • Familiarity with research methods is desirable.
    • Public speaking and educational training experience is desirable.
  • Personal traits and characteristics:
    • Able to work effectively with others; possess excellent interpersonal & communication skills.
    • Able to take initiative.
    • Willingness to accept responsibility, and to show good judgement and resourcefulness.
    • Willing to adhere to the principles of confidentiality governing research work, and to the ORI computer acceptable use policy.
    • Must value working in a collaborative environment.

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work is conducted in an office environment with some travel to sites required. Constant hearing, seeing, talking, and sitting. Frequent hand, wrist, finger movement and viewing a computer monitor.

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