Reports to the Lifespan Director Research Protections Office. Assists research investigators in complying with federal state and institutional policies and regulations regarding the conduct of biomedical research in health care institutions. For Lifespan partners serves as a resource to ensure institutional compliance with regulations regarding the ethical review of research projects involving (but not limited to) human subjects animals and biohazards. Participates in the formation and revision of Lifespan procedures and policies regarding the review and conduct of biomedical research in the Lifespan system.
Creates executes and maintains compliance and operational plans to meet the federal regulatory requirements necessary to conduct research using human subjects.
Performs the initial review of all new research protocols and all new expedited applications. Will triage applications to committees and resolve problem applications before assignment to and IRB.
Serves as the research HIPAA compliance officer in the execution of HIPAA related research forms.
Ensures ongoing fidelity of Lifespan?s accredited program (AARPP) with overall responsibility of coordinating policies and procedures and our accreditation documents.
Identifies needs and assists in developing corporate research policies and procedures for the review and conduct of research activities involving human subjects.
Coordinates the activities of the various federally mandated research review committees that include three human subjects institutional review boards (IRBs) across the Lifespan affiliated hospitals.
Provides support staff for the various research review committees and may serve as an alternate member of an IRB. Acts a communications liaison between the committees and the investigator.
Orients and initially trains all new IRB members prior to their assignment to on IRB.
Maintains knowledge and understanding of current federal state and institutional regulations policy statements and procedures governing research review committees and the conduct of health care research in general.
Will serve as a resource person for investigators and other research administrators within Lifespan for information regarding the application of and changes in federal state and institutional regulations policies and procedures as the relate to the review and conduct of research in health care. Will serve as a trainer in Lifespan?s ongoing program(s) of regulatory compliance.
Orients assigns work to trains communicates with supervises and appraises support staff involved in the daily activities of processing research applications for the various research review committees maintenance of research project files and computer data bases and compliance regulatory issues as the relate to the conduct of research.
Participates in research management team meetings improvement teams and other supervisory/management meetings as needed. Attends periodic management training seminars and professional conferences within and outside the Lifespan system.
Baccalaureate degree in health sciences and/or administration.
Master?s degree in related field preferred.
At least four years progressively more responsible related experience preferably in a leadership capacity in research administration working with research review committees and demonstrating knowledge of and ability to interpret related requirements and regulations.
Direct supervision of research review committee coordinators and assistants.