Fariba Houman Email & Phone Number

Boston, Ma, Us

Boston, Ma, Us

Boston, Ma, Us

• Oversee IRB and research privacy operations, systems, and overall human research program for Massachusetts Eye and Ear Infirmary and Schepens Eye Research Institute. Responsible for creating policies and procedures, and compliance with regulations (FDA, GCP, OHRP, HIPAA). Advise executive leadership on regulatory issues, provide gap analysis, and report to agencies as required. Support investigators in communicating with the FDA and submitting IND and IDE applications; Provide regulatory advice and training to investigators and IRB members• Work closely with clinical research administrators for coverage analysis, compliance with clinical trial results posting per FDA requirements; responsible for assessing COI and grant congruence, conducting site visits and root-cause analyses of non-compliance as needed• Responsible for engagement determination and reliance agreements with external academic or commercial IRBs• Engage relevant institutional stakeholders to develop institution-wide policies and procedures• Supervise 4 FTE involved in regulatory review, and QA/QI and Education

Boston, Ma, Us

• Institutional Review Board Member• Conducted initial and continuing review of human subjects research protocols in accordance with federal regulations• Reviewed and approved protocol analysis by IRB Review Specialists• Supervised and managed 3 direct reports• Participated in development and implementation of policies and procedures• Advised investigators and university-wide administrative offices on IRB questions• Financial Administrator responsible for approval of all financial transactions and personnel actions

Boston, Massachusetts, Us

• Designed and managed administrative processes for review of safety monitoring to enhance clinical research oversight effectiveness• Developed and implemented SAEF (Serious Adverse Event Forum), a secure online portal for AE review• Coordinated review of adverse events and unanticipated problems involving risks to subjects or others • Managed the accounts payable processes and shared hiring and firing responsibilities with the Director • Collaborated with the Sponsored Programs Administration on shared processes

Boston, Massachusetts, Us

• Organized and managed the operation, administration, and finance of a multi-project collaborative research and training program involving 9 scientists in Senegal and Nigeria and 3 at HSPH• Managed expenditure ($2M budget) for the international operation • Coordinated IRB review of five studies in Senegal, Malawi, and Nigeria• Coordinated timely submission of international collaborative grants, contributed to the writing and budget preparation in collaboration with three scientists and the PI• Managed Visiting Scholars visits including academic appointment, lodging, visa, travel, classes, and insurance• Managed shipping of hazardous biological samples, supplies, and equipment

Us

Lexington, Ma, Us

Boston, Ma, Us

Doctor Of Philosophy (Ph.D.), Molecular Biology And Microbiology

Fellowship In Bioethics, Center For Bioethics

Jane Coffin Childs Postdoctoral Research Fellow

Bachelor Of Arts (B.A.), Biology With A Minor In Italian Literature