- Conducts specialized analyses of study submissions and manages the review process throughout the life of a research proposal to ensure that the University meets its obligations in the review of all human subjects' research by interpreting the federal regulations in a method that is workable and has practical application for abstract and complex ethical, scientific and legal issues. Maintains involvement in all phases of the review process: before the proposal submission to facilitate the review process by serving as consultant to the investigator; during the review process by interacting with the investigator, OHR staff members, the Board and other offices/departments, making recommendations and suggesting alternatives; and after the approval process by counseling investigators regarding changes in study parameters, assisting in and/or mediating issues.
- Provides guidance to OHR staff to ensure efficient and effective processing of protocols, which includes the formulation of acceptable solutions to resolve issues that affect research subject's rights and welfare. Advises components of the Human Research Protection Program (HRPP), including departments, investigators, board members, and other office personnel, in the resolution of critical issues related to compliance with human subject research regulation and institutional policy to ensure adequate and appropriate reviews of research.
- Oversees the GW Reliance Program to ensure a robust and effective program that complies with federal regulations and institutional policy.
- In collaboration with the Director, Regulatory Oversight and other staff in the Office for Research Integrity & Compliance, facilitates the development and refinement of appropriate human subject research training programs to ensure OHR staff members, IRB members, and researchers are properly educated about their ethical and regulatory responsibilities.
- Conducts training sessions for faculty, staff and students in matters related to the welfare of human subjects, ethics, and other areas as may be required to meet federal, local and University standards in research that will protect the rights and welfare of human subjects.
- Oversees the distribution of and training on Human Research Protection Program (HRPP) policies and procedures, including internal processes and forms.
- Develops and recommends changes in HRPP policies and procedures in concert with the Director, Regulatory Oversight to promote the protection of the rights and welfare of human research subjects. Maintains an awareness of issues related to human subject research; develops and updates appropriate policies and procedures for the research community.
- Collaborates with the Director, Regulatory Oversight and other HRPP leadership on long-term projects as needed, for example, HRPP Accreditation. Performs other duties as assigned. The omission of specific duties do not preclude the supervisor from assigning duties that are logically related to the position. Minimum Qualifications:
- Graduate degree, Master's or PhD preferred.
- Possess excellent interpersonal, communication, and leadership skills and the ability to work effectively with team members, stakeholders, and researchers.
- Able to work effectively in an environment that requires constant evaluation and shifting of priorities to respond to the needs of the University research community.
- Demonstrates critical thinking and flexibility in decision-making, balancing regulatory compliance requirements against practical needs and limitations in the application of policies and regulations.
- Exercises diplomacy in day-to-day interactions.
- Experience reviewing both social behavioral research and biomedical research.
- Experience with AAHRPP accreditation process.
- Experience with SMART IRB and reliance agreements.
- Experience managing electronic regulatory committee submission and review systems.
- Experience managing staff. Hiring Range Commensurate with Experience
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Assistant Director, Office of Human Research - Washington, United States - The George Washington University
Description
I. JOB OVERVIEW Job Description Summary: The Office of Human Research (OHR) supports The George Washington University research community in the conduct of innovative and ethical research by providing guidance, education, and oversight for the protection of human subjects. The Assistant Director, Office of Human Research reports to the Director,Regulatory Oversight and manages the day-to-day operations of Office of Human Research, including the OHR staff members.The specific duties and responsibilities include:
Qualified candidates will hold a Bachelor's degree in an appropriate area of specialization plus 6 years of relevant professional experience, or, a Master's degree or higher in a relevant area of study plus 4 years of relevant professional experience. Degree must be conferred by the start date of the position. Degree requirements may be substituted with an equivalent combination of education, training and experience.
Additional Required Licenses/Certifications/Posting Specific Minimum Qualifications: Candidates must have current certification as an IRB Professional (CIP) or obtain certification within 6 months of hire. Preferred Qualifications:
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