Boston Location; Full time 40 hours per week
Provide complex analytical and regulatory support of the confidential institutional review and approval process of all proposed human research activities to protect the safety, rights and welfare of subjects. Performs regulatory review of research protocols and related documents submitted to the HSC for compliance with federal and state regulations and Mass. Eye and Ear institutional policies. Exercises the authority as a HSC member to 1) make not-human-subjects/exemption determinations; 2) approve non-exempt, minimal risk research using the expedited review procedure; 3) approve minor changes to approved research not otherwise eligible for expedited review; 4) conduct substantive pre-reviews of research requiring full committee review; 5) establish full committee meeting agendas and compose regulatory-compliant HSC meeting minutes and letters to investigators. In addition, the IRB Review Specialist ensures that research protocols are congruent with grants and contracts and participates in HRPP-related QA/QI and accreditation activities as needed.
EDUCATION AND EXPERIENCE:
BS/BA required, Master’s degree preferred, preferably a field relevant to biomedical research. Three year minimum work experience in IRB protocol review, preferably in a biomedical IRB office. Must be able to understand and independently interpret and apply OHRP, FDA, and Privacy regulations. Excellent written and oral communications skills; strong analytical, time management, and multi-tasking skills; ability to follow through on assignments with minimal direction, ability to prioritize work independently and work under tight deadlines; ability to work effectively and diplomatically with a broad range of researchers. Ability to maintain confidentiality. Comprehensive knowledge of Microsoft Office Suite is required. Knowledge of IRBNet system is a plus. CIP certification required.