QUALITY ASSURANCE/QUALITY CONTROL MANAGE, School of Medicine, Associate Provost

QUALITY ASSURANCE/QUALITY CONTROL MANAGE, School of Medicine, Associate Provost Tracking Code22500561490517Job DescriptionThis new position reports to the Boston University Clinical and Translational Science Institute (BU-CTSI) Executive Director and is responsible for all aspects of the BU CTSI prior approval requests and submissions related to the NIH/NCATS Prior Approval and Reporting of Research with Human Subjects and/or Vertebrate Animals requests. The CTSI Quality Assurance/Quality Control (QA/QC) Manager serves as a quality control and program management expert for these requests and develops and implements streamlined processes to address the delays in moving biomedical discoveries through the translational spectrum for the BU CTSI. The CTSI QA/QC Manager will collaborate with the NCATS CTSA Program Quality Assurance/Quality Control (QA/QC) Group to discuss challenges and best practices related to ensuring the submission of successful CTSA-related information packages to NCATS for KL2 projects and pilots that conduct research with human subjects. They will also share information and propose improvements regarding this process. The new position builds on existing administrative and regulatory personnel and processes already established by the BU CTSI, the Office of Human Research Affairs (OHRA), the Institutional Review Board (IRB) and the Clinical Research Resources Office (CRRO). This will include developing new tools, creating efficient and consistent processes, and ensuring quality reviews, and establishing consistency and compliance with CTSA-related submissions to NCATS.
Required SkillsBachelors degree in research or related area plus five years of clinical trials/research experience or equivalency required; demonstrated human relations and effective oral and written communication skills required. Masters or doctoral degree in research or related area preferred. Regulatory experience, familiarity with Quality Assurance and Quality Control (QA/QC) and Project Management concepts; Human Subjects Research Regulations; and Institutional Processes surrounding human subjects research required.

Please note all newly hired staff and faculty, will need to be in compliance with Boston University's COVID-19 Vaccination and Booster [Requirement](https://www.bu.edu/hr/hr-covid-19-resources/vaccine-required-for-faculty-and-staff/) within 30 days of date of hire. You must upload your vaccine documentation or request a medical or religious exemption ([instructions](https://www.bu.edu/hr/hr-covid-19-resources/upload-your-covid-vaccination-documentation/)). For further information on the University's response to COVID-19, please visit the [Back2BU site](https://www.bu.edu/back2bu/).

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, 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.
Job LocationBOSTON, Massachusetts, United StatesPosition TypeFull-Time/Regular