HUMAN RESEARCH QUALITY MANAGER, School of Medicine, Clinical Research
HUMAN RESEARCH QUALITY MANAGER, School of Medicine, Clinical Research
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Job 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 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.
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 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.
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.
Required Experience:
Manager
Employment Type
Full-Time
