REGULATORY EDUCATION MANAGER, School of Medicine, Clinical Research - Boston University
BOSTON, MA
About the Job
The Clinical Research Resources Office (CRRO) isan 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) Regulatory 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, guidance's, policies and best practices guiding clinical and human subject's 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.
- 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 social behavioral 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 therole, 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 COVID-19 Resources site.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, natural or protective hairstyle, 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.