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 Lifespan Institutional Review Board Reviewer supported by the Lifespan IRB Human Research Protection Program (HRPP) reviews and monitors all research involving human subjects conducted by Lifespan employees as well as all research conducted at any Lifespan 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 Lifespan Human Research Protection Program and Lifespan Institutional Review Boards. 

The role helps to ensure all research activities comply with federal regulations state and local law and institutional policies and AAHRPP accreditation standards in the conduct of biomedical and behavioral human subject research activities conducted by Lifespan employees or research affiliates.

 

Responsibilities:

Review biomedical and behavioral research studies for compliance with Federal regulations and Institutional (Lifespan/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.

 

Lifespan is an Equal Opportunity / Affirmative Action 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.   Lifespan is a VEVRAA Federal Contractor.

 

Location: Corporate Headquarters USA:RI:Providence

 

Work Type: Per Diem

 

Shift: Shift 1

 

Union: Non-Union

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