HUMAN RESEARCH QUALITY MANAGER, School of Medicine, Clinical Research at Boston University in Boston, MA

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 remote 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. The incumbent 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 and Masters Degree preferred. •Experience in auditing is not required but 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 in auditing not required but at least 4 years experience working within human subjects research in positions such as an IRB staff/analyst, study coordinator, or monitor/auditor is needed. •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 REDCap functionalities and experience with developing, implementing or modifying REDCap instruments (should be comfortable with creating data collection forms and/or surveys in REDCap). •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. 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 remote 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. He/she 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.

Skills

Required Skills Bachelors Degree required and Masters Degree preferred.

Experience in auditing is not required but at least 4 years' experience working within human subject's research in positions such as IRB staff/analyst, study coordinator, or monitor/auditor is required.
Experience in auditing not required but at least 4 years' experience working within human subject's research in positions such as an IRB staff/analyst, study coordinator, or monitor/auditor is needed.
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 REDCap functionalities and experience with developing, implementing or modifying REDCap instruments (should be comfortable with creating data collection forms and/or surveys in REDCap).
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. 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 remote 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. He/she 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.

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.