The Human Research Protection Program (HRPP) Human Research Quality Manager will perform quality assurance monitoring and auditing on human research studies conducted at BMC and BU Medical Campus. The Human Research Quality Manager will evaluate and verify adherence to applicable regulations, laws, and policies and to the IRB approved protocols. This individual conducts on-site and remote reviews of IRB-approved research studies to ensure that research is conducted in compliance with applicable regulations, policies, and mentorship. These include both for-cause audits as well as not-for-cause (Quality Assurance) reviews of human and clinical research studies at BMC and BU Medical Campus. As a function of the QA role, this individual will provide assistance to clinical researchers regarding regulatory aspects to the conduct of research throughout the life of the study, especially concentrating on issues that come up in QA reviews. He/she will work with the CRRO Regulatory Education Manager and others within the Human Research Protection Program in identifying and developing educational priorities and quality improvement initiatives. As applicable, this individual will be involved in local and national efforts to support the conduct of clinical research, including involvement in Clinical Translational Science Award (CTSA) task-forces and subcommittees related to research monitoring/auditing, regulations, research conduct, and trials registration. This is a highly visible position that involves significant contact with BMC and BU Medical Campus investigators and the IRB. Excellent presentation, written and verbal communication skills are required.
Bachelors Degree required and Masters Degree preferred
Experience in auditing is not required but at least 4 years experience working within human subjects' research in positions such as IRB staff/analyst, study coordinator, or supervise/auditor is needed
Experience in auditing not required but at least 4 years experience working within human subjects' research in positions such as an IRB staff/analyst, study coordinator, or monitor/auditor is needed
Experience with conduct of clinical research either with pharmaceutical/device clinical trials and or observational or socio behavioral and/or public health research
Knowledge of REDCap functionalities and experience with developing, implementing or modifying REDCap instruments (should be comfortable with crafting data collection forms and/or surveys in REDCap)
Knowledge of HIPAA regulations for research
Experienced understanding of policies and regulations guiding human research, including FDA, OHRP, ICH GCP, applicable NIH policies, etc
Excellent writing skills required
Excellent social skills required
Must be comfortable giving presentations to and working with small and large groups of people
Ability to multi-task
Strong digital literacies, including experience with databases, spreadsheets, Microsoft PowerPoint, word processing, etc
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. We are a VEVRAA Federal Contractor.
Internal Number: 0623
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