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The Boston Medical Center and BU Medical Campus Office of Human Research Affairs (OHRA) Human Research Quality Manager will be responsible for managing and performing Quality Assurance activities within the Human Research Protection Program (HRPP). The Human Research Protection Program (HRPP) has the responsibility to evaluate and improve the conduct of research that it oversees. Consistent with this responsibility, the HRPP may perform targeted audits or Quality Assurance (QA) reviews for research studies at Boston Medical Center and Boston University Medical Campus. The Senior Human Research Quality Manager will work under the direction of the Director of the Clinical Research Resources Office (CRRO) as the lead auditor, along with one full-time and one part-time staff.
This individual will assist in developing/refining processes to identify research studies to select for QA reviews, which are brief quality assurance “checks” at early stage of the conduct of the research with the goal to help investigators and study staff perform their research in compliance with applicable regulations, policies and guidance to ensure safety of research participants and reliability/validity of study data.
This individual will assign reviews to staff as well as conduct reviews, and complete written reports to the Principal Investigator identifying areas of non-compliance and providing advice on implementation of best practices to assure ethical conduct of research. This individual will also conduct for-cause audits and assign other QA staff to audits as needed. For-cause are audits requested (usually by the IRB) in response to information that indicates that there may be a risk to subject safety or to the validity of the study data. Along with the other QA staff members this individual will advise investigators on reporting of findings to the IRB (and other entities, as necessary) as well as advise on the development of Corrective and Preventative Action plans (CAPA), as necessary. 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 Director and the Regulatory Education Manager in identifying and developing educational priorities. This individual may also assist in investigator consultations including questions on study implementation, preparation for FDA inspections, assistance with FDA IND/IDE requirements, informed consent process and issues, HIPAA issues, DSMP development, etc. The Human Research Quality Manager will also be involved in local and national efforts to support the conduct of clinical research. This includes involvement in applicable Clinical Translational Science Award (CTSA) task forces and subcommittees related to research coordination, regulations, research conduct, auditing, and registration.
5 years of experience and a Bachelor's degree required.
This individual must be detail-oriented and have the ability to multi-task. Experience in auditing is strongly preferred. Experience in clinical research and advanced knowledge of regulations/guidance guiding human research, including HHS/OHRP, FDA, ICH GCP, etc. is required. Master's Degree preferred.
Strong verbal and written communication skills and excellent interpersonal skills are required. Strong computer skills, including experience with databases, spreadsheets is required. Knowledge of HIPAA regulations for research, experience submitting IRB applications and managing IRB submission efforts are also desired.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. We are a VEVRAA Federal Contractor.
About Boston Medical Center and BU Medical Campus Office of Human Research Affairs
Boston Medical Center and the three schools on the Boston University Medical Campus (Medicine, Public Health, and the Goldman School of Dental Medicine) are committed to performing human research in order to advance our understanding of health and disease. This research must be conducted according to the highest ethical standards and in compliance with all regulatory requirements. The Office of Hu...man Research Affairs (OHRA) is responsible for the oversight of this human research to assure that we meet those ethical and regulatory expectations.