Job Description
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 virtual reviews of IRB-approved research studies to ensure that research
is conducted in compliance with applicable regulations, policies, and guidance. 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. This individual 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) taskforces 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.
Required
Skills
Please note all newly hired staff and faculty, will need to be in compliance
with Boston University’s COVID-19 Vaccination and Booster Requirement within 30 days of
date of hire. You must upload your vaccine documentation or request a medical or religious exemption (instructions). For further
information on the University’s response to COVID-19, please visit the Back2BU
site.
We are an equal opportunity employer and all qualified applicants will receive consideration for
employment without regard to race, color, religion, sex, age, national origin, physical or mental disability, sexual orientation, gender
identity, genetic information, military service, pregnancy or pregnancy-related condition, or because of marital, parental, or veteran
status. We are a VEVRAA Federal Contractor.
Position Type
Full-Time/Regular
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