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REGULATORY EDUCATION MANAGER, School of Medicine, Clinical Research

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

REGULATORY EDUCATION MANAGER, School of Medicine, Clinical Research

Tracking Code22500404180128Job Description

The Clinical Research Resources Office (CRRO) is is an office under the Human Research Protection Program (HRPP), which is a shared program of Boston Medical Center and BU Medical Campus. The CRRO provides support to all levels of the research team, in the form of consultations and trainings with the overall goal in ensuring that clinical and human research conducted here meets and exceeds ethical and regulatory standards and adheres to best practices.

The Clinical Research Resources Office (CRRO) Human Research Education Manager will manage two important aspects of the HRPP: the Research Professionals Network (RPN) and the human/clinical research education and training for Boston University and Boston Medical Center researchers (PIs and study staff). Education will promote understanding and compliance with the regulations, guidances, policies and best practices guiding clinical and human subjects research. Education includes group educational offerings as well as individual, study-specific consultations on IRB application submissions, protocol planning, and study implementation. This also may include development of video education options. This person will organize, maintain and develop current and new educational offerings on Good Clinical Practice (GCP) and proper conduct of research for all levels of the clinical/human research team. The Human Research Education Manager works within the CRRO (under the Office of Human Research Affairs) as well within the BU Clinical and Translational Science Institute (CTSI) Regulatory and Workforce Development Programs and helps to ensure activities support the BU CTSI’s mission and goals.

Essential job functions:

  • Develop, maintain and continually improve ongoing educational offerings of the Clinical Research Resources Office (CRRO), including PI training, coordinator trainings, and workshops on informed consent and AE monitoring. Update trainings based on identified needs, QA findings, new regulations and guidance, etc. Manage the monthly Clinical Research Seminars and other similar educational offerings as they are developed.

  • Provide consultations in the form of direct, one-on-one and small group education on regulatory aspects to the conduct of research throughout the life of the study, including: investigator and sponsor responsibilities, study conduct, adverse event reporting, documentation, consenting, protocol planning, IRB submissions, questions on study implementation, assistance with FDA IND/IDE submissions, consent development and writing, HIPAA issues, DSMP development, planning and submitting protocols to the IRB.

  • Working with the Quality Assurance team to understand issues that come up in QA Reviews and audits that should be translated to education and other quality improvements.

  • Develop, maintain and manage the Research Professionals Network (RPN) for the Boston Medical Center (BMC) and Boston University Medical Campus research staff who have research coordinator responsibilities (regardless of job title). The goal of the Research Professionals Network is to enhance opportunities for education, professional development, and networking to share best practices for the conduct of clinical and human research. This includes management of our inter-institutional collaboration offering monthly peer-led, competency-based RPN Workshops. This may include work on development of research staff career ladders.

  • Involvement in local and national efforts to support the conduct of clinical research, especially as it pertains to coordinators and other research support staff is an essential function of this position. This includes involvement in Clinical Translational Science Award (CTSA) taskforces and subcommittees related to research coordination, regulations, research conduct, auditing, and registration. Works on regulatory projects and initiatives as needed.

Required Skills
  • 5 - 8 years relevant experience working as a clinical research coordinator role (project manager, research assistant, study coordinator, etc.) and/or working as an IRB analyst/human subjects protection role, or Master's and 4 or more years of relevant experience.
  • Experience with conduct of clinical research with pharmaceutical/device clinical trials and/or observational or sociobehavioral and/or public health research.
  • Experience successfully submitting IRB applications and managing IRB submission efforts.
  • Prior experience working as an IRB analyst is extremely beneficial to the this role, but not required.
  • Excellent interpersonal skills required. Must be comfortable giving presentations to and working with small and large groups of people.
  • Demonstrated knowledge of clinical/human research conduct, GCP, Federal regulations guiding human research (21 CFR 312, 812, 50, 56, etc. and 45 CFR 46)
  • Detail oriented. Ability to multi-task.
  • Strong computer skills, including experience with databases (and in particular REDCap), spreadsheets, Microsoft PowerPoint, word processing, Adobe, etc.

- Experience developing trainings and giving presentations to large and small groups.

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, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. 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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