Inside Higher Ed
HUMAN RESEARCH QUALITY MANAGER, School of Medicine, Clinical Research
Inside Higher Ed, Boston, Massachusetts, us, 02298
HUMAN RESEARCH QUALITY MANAGER, School of Medicine, Clinical Research
The Human Research Quality Manager will perform quality assurance monitoring and auditing on human research studies conducted at BMC and BU Medical Campus. The role evaluates adherence to applicable regulations, laws, policies, and IRB-approved protocols. The QA conducts on-site and remote reviews of IRB-approved research to ensure that research is conducted in compliance with applicable regulations, policies, and guidance. This includes for-cause audits as well as not-for-cause (Quality Assurance) reviews of human and clinical research studies at BMC and BU Medical Campus. The role provides assistance to clinical researchers regarding regulatory aspects to the conduct of research throughout the life of the study, concentrating on issues identified in QA reviews. The role collaborates with the CRRO Regulatory Education Manager and others within the Human Research Protection Program to identify and develop educational priorities and quality improvement initiatives. The role may involve 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 with significant contact with BMC and BU Medical Campus investigators and the IRB. Excellent presentation, written and verbal communication skills are required.
Required Skills
Bachelor\'s Degree required and master\'s 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 with conduct of clinical research either with pharmaceutical/device clinical trials and/or observational or behavioral and/or public health research.
Knowledge of REDCap functionalities and experience with developing, implementing or modifying REDCap instruments (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, NIH policies, etc. Excellent writing skills required.
Excellent interpersonal and presentation skills; ability to work with small and large groups.
Detail oriented; ability to multi-task.
Strong computer skills, including experience with databases, spreadsheets, Microsoft PowerPoint, and word processing.
Equal Opportunity Employer:
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability, sexual orientation, gender identity, genetic information, military service, pregnancy or pregnancy-related condition, or marital or veteran status. We are a VEVRAA Federal Contractor.
To apply, visit:
https://jobs.silkroad.com/BU/External/jobs/315595
#J-18808-Ljbffr
Required Skills
Bachelor\'s Degree required and master\'s 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 with conduct of clinical research either with pharmaceutical/device clinical trials and/or observational or behavioral and/or public health research.
Knowledge of REDCap functionalities and experience with developing, implementing or modifying REDCap instruments (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, NIH policies, etc. Excellent writing skills required.
Excellent interpersonal and presentation skills; ability to work with small and large groups.
Detail oriented; ability to multi-task.
Strong computer skills, including experience with databases, spreadsheets, Microsoft PowerPoint, and word processing.
Equal Opportunity Employer:
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability, sexual orientation, gender identity, genetic information, military service, pregnancy or pregnancy-related condition, or marital or veteran status. We are a VEVRAA Federal Contractor.
To apply, visit:
https://jobs.silkroad.com/BU/External/jobs/315595
#J-18808-Ljbffr