IRB Reviewer PD

Summary:

The Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) regulations require an Institutional Review Board (IRB) to review all human subject research proposals so as to "protect the rights and welfare of human subjects." The Brown University Health Institutional Review Board Reviewer, supported by the Brown University Health IRB Human Research Protection Program (HRPP), reviews and monitors all research involving human subjects conducted by Brown University Health employees as well as all research conducted at any Brown University Health research affiliated institution. This position is an IRB committee member designated to conduct and approve review of biomedical and behavioral research involving human participants on behalf of the Brown University Health Human Research Protection Program and Brown University Health Institutional Review Boards.

Responsibilities:

Review biomedical and behavioral research studies for compliance with Federal regulations and Institutional (Brown University Health/HRPP) policies and procedures. Identify issues or concerns that must be addressed in order to approve the research under the expedited procedure, or exempt criteria. Research reviews may include new and continuing review of studies, modifications, etc.

Provide justification for exempt or expedited classification or refer the submission to the full board committee if a higher level of review is appropriate.

Communicate with investigators to facilitate the review process while incorporating complex scientific and regulatory language and concepts, in addition to relevant ethical concerns, if any. Contingencies (requests for changes or clarifications) should be consistent with HRPP guidelines, regulatory guidance and education as applicable. Communications must be clear, concise, and grammatically correct.

Maintain a working knowledge of current regulations, guidelines, and trends influencing the conduct of human subject research.

Consult with other experts as needed to conduct informed, qualitative review of biomedical and behavioral research involving human participants. Experts may include physician-scientists or other clinical professionals, HRPP colleagues and scientists in the social-behavioral-educational sciences, HRPP and Institutional colleagues in research administration.

Creates, executes, and maintains compliance and operational plans to meet the federal regulatory requirements necessary to conduct research using human subjects.

May serve as a research HIPAA Privacy reviewer, as designated, in the execution of HIPAA related, research matters.

May serve as a resource for other IRB members and perform educational presentations (formal and informal) as designated.

May participate in special projects, development of guidance documents, and/or quality assurance/improvement assessments.

Other information:

QUALIFICATIONS-EDUCATION:

Baccalaureate degree in science preferred.

Certified IRB Professional (CIP) Certification recommended.

QUALIFICATIONS-EXPERIENCE:

Must have working knowledge of the federal regulations governing research, including HIPAA regulations.

Former experience as an IRB member or IRB administrative experience including review and processing of submissions and management of IRB meetings preferred.

Expert ability to interpret, analyze, apply and communicate applicable ethical principles, laws, regulations, guidance that apply to human subject research.

Demonstrated ability to provide proactive, flexible and customer service focused feedback; work effectively with others; and demonstrate ethics and integrity in a professional matter, sensitivity to confidentiality, and a commitment to protecting research participants.

Demonstrated technology and software applications kills with ability to learn new software; highly skilled in office productivity software and knowledge of technology platforms used in research.

SUPERVISORY RESPONSIBILITIES:

None.

Brown University Health is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, ethnicity, sexual orientation, ancestry, genetics, gender identity or expression, disability, protected veteran, or marital status. Brown University Health is a VEVRAA Federal Contractor.

Location: Brown University Health Corporate Services, USA:RI:Providence

Work Type: Per Diem

Shift: Shift 1

Union: Non-Union