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HUMAN RESEARCH QUALITY MANAGER,MED School of Medicine, Clinical Research

Employer
Boston University
Location
BOSTON, Massachusetts, United States
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Job Details

HUMAN RESEARCH QUALITY MANAGER,MED School of Medicine, Clinical Research

Tracking Code22500417580328Job 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

  • Bachelors Degree required; Masters Degree preferred.
  • Experience in auditing clinical and human research is preferred, but not required.
  • At least 4 years experience working within human subjects research in positions such as IRB staff/analyst, study coordinator, or monitor/auditor is needed.
  • Experience using REDCap preferred.
  • 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 HIPAA regulations for research.
  • Expert understanding of policies and regulations guiding human research, including FDA, OHRP, ICH GCP, applicable NIH policies, etc.
  • Excellent writing skills required.
  • Excellent interpersonal skills required.
  • Must be comfortable giving presentations to and working with small and large groups of people.
  • Detail oriented. Ability to multi-task.
  • Strong computer skills, including experience with databases, spreadsheets, Microsoft PowerPoint, word processing, etc.

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.

Job LocationBOSTON, Massachusetts, United StatesPosition TypeFull-Time/Regular

Organization

The Difference Is Our DNA

What compelled the Bill & Melinda Gates Foundation to award Boston University a grant to fight newborn mortality in Zambia? Why did Martin Luther King, Jr. adopt BU as a place where he could hone his message of justice and equality? And what is the catalyst that prompts 32,557 students from 135 countries to call BU their home every semester? It’s in our DNA: an inherent desire in each of our students, faculty, and staff to vigorously and dauntlessly pursue knowledge—and embrace the unlimited possibilities that come with it.

A Community Unlike Any Other

As you can see below, it takes people, ideas, and a little luck (Boston, you’re our town) to make BU what it is today: one of the most dynamic universities in the world.

Celebrated thinkers: On any given day, students will find themselves mesmerized by Nobel Prize winners, a poet laureate, and the first biomedical engineer ever to receive a MacArthur Foundation “Genius Award,” among others.

Extraordinary teaching: When a classroom starts to percolate with new ideas, it’s because our faculty of scholars and accomplished practitioners know how to ignite students’ imaginations. That’s why we reward our best teachers with BU’s most prestigious honor: The Metcalf Cup and Prize.

Groundbreaking research: With faculty dedicated to a creative, interdisciplinary approach to problem solving, BU has become a leading global research institution—propelled forward by over $350 million a year in sponsored program revenue.

World-class students: Elite students from all 50 states and 135 countries pursue higher education on BU campuses in Boston and at programs in L.A., D.C., and more than 30 other cities on six continents.

A city within a city: Today, 80% of our undergrads live on campus, which could explain the 525 student activity groups alone.

The greatest college town in the world: Boston. ’Nuff said.

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