CTU Data Quality Assurance Manager
Permanent Staff (EHRA NF)Department:
Globl Hlth and Infect Disease-427801Working Title:
CTU Data Quality Assurance ManagerAppointment Type:
EHRA Non-Faculty ResearchPosition Posting Category:
Research ProfessionalsFull Time/Part Time?:
Full-Time PermanentHours per Week:
20038073Posting Open Date:
04/20/2021Open Until Filled:
NoProposed Start Date:
The UNC Global Infectious Diseases Clinical Trials Unit (CTU) received a seven year grant from the Division of AIDS (DAIDS) to perform HIV and other infectious disease research at four clinical research sites (CRSs). These sites are located in Chapel Hill, NC; Greensboro, NC; Lilongwe, Malawi; and Hanoi, Vietnam. The Vietnam site is new to the CTU and will require additional oversight, training, and review of processes as it transitions to becoming a fully functional CRS.
The CTU Data Quality Assurance Manager is a member of the CTU Operations Team and is responsible for overseeing the data quality management at each CRS. Quality assurance metrics include but are not limited to: Oversight of CRS Quality Assurance Plans to ensure they meet Federal, State, and Local Regulations, as well as GCP and sponsor regulations; Creation of CTU-wide SOPs; Review of CRS-specific data management activities, Review and assessment of key quality indicators and coordinating with CRS data managers to implement quality improvement measures as metrics are evaluated. The CTU Data Quality Assurance Manager reports to the CTU Leadership and CRS Leaders/Coordinators the need for additional training and mentorship activities. The CTU Data Quality Assurance Manager trains and mentors CRS staff in regards to data quality assurance. The person in this role is the primary liaison with DAIDS, UNC, and CRS’s local institutions to oversee the implementation of the DAIDS-mandated transition to electronic source documentation and remote monitoring. This includes creating and maintaining systems that can be used at each of the four CRSs for remote monitoring and electronic source documentation.Educational Requirements:
Relevant post-Baccalaureate degree required; for candidates demonstrating comparable independent research productivity, will accept a relevant undergraduate degree and 3 or more years of relevant experience in substitution. May require terminal degree and licensure.Qualifications and Experience:
At least five years experience working on DAIDS funded studies at a management level. The person in this role must have previous experience working with DAIDS and the NIH in general. DAIDS has specific requirements related to the conduct of clinical research that must be followed at all sites participating in DAIDS-funded research. Detailed familiarity with these requirements and how they must be implemented at sites is required to perform this position. The ideal candidate in this role will have had direct experience working within specialized study network committees funded by DAIDSEqual Opportunity Employer :
The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or status as a protected veteran.