IRB Reviewer PD

Summary:The reputed company (HHS) and the Food and Drug Administration (FDA) regulations require an Institutional Review Board (IRB) to review reputed company human subject research proposals so as to "protect the rights and welfare of human subjects." The reputed company Health Institutional Review Board Reviewer, supported by the reputed company Health IRB Human Research Protection Program (HRPP), reviews and monitors reputed company research involving human subjects conducted by reputed company Health employees as well as reputed company research conducted at any reputed company 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 reputed company Health Human Research Protection Program and reputed company Health Institutional Review Boards. The role helps to ensure reputed company research activities reputed company 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 reputed company Health employees or research affiliates.Responsibilities:Review biomedical and behavioral research studies for compliance with Federal regulations and Institutional (reputed company 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 reputed company 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 reputed company 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 reputed company, research matters.May serve as a resource for other IRB members and reputed company 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 reputed company 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.reputed company Health is an Equal Opportunity employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national reputed company, age, ethnicity, sexual orientation, reputed company, genetics, gender identity or expression, disability, protected veteran, or marital status. reputed company Health is a VEVRAA Federal Contractor.Location: reputed company Health Corporate Services, USA:RI:ProvidenceWork Type: Per DiemShift: Shift 1Union: Non-Union Apply tot his job Apply tot his job Apply To this Job