Under the supervision of the AntiViral Research Center (AVRC) Director of Operations, the incumbent is responsible for all data management and quality assurance functions that will ensure timely progression and analysis of NIH-funded AIDS Clinical Trials Group (ACTG) clinical research protocols. Manages clinical research data for all AIDS Clinical Trials Group (ACTG) protocol (approximately 20). Prepares, coordinates, tracks completion and correction of paper case report forms. Completes electronic case report forms using source documents. Performs data quality management by reviewing and auditing CRF's and source documents to check data logic, identify delinquencies, generate and resolve data queries. Cleans, organizes and imports/exports data files and generates several weekly and monthly reports for the research team for quality management purposes and to provide follow up statistics to monitor study accrual and conduct. Communicates with clinical research nurses, Principal Investigators and other research staff as well as the central data management center to ensure timely and accurate collection and reporting of quality data. Oversees and performs data entry, randomizations, database corrections, and report generation using web-based database. Attends national meetings, participates in conference calls as necessary. Advanced computer skills to include Word, Excel, Access and various programming languages. Leads all data management activities for the ACTG data group which includes training of new employees, requesting access to systems for all ACTG staff at the UCSD site, delegates tasks to student employees and other data associates. Communicates between the site and the central data center to keep communication list serves up to date for each study. Leads the team in source document creation for all new and ongoing projects.

• Theoretical knowledge or Bachelor's degree in a biological life science or related discipline or equivalent education and experience.

• Demonstrated experience with clinical research activities and guidelines related to consent, ethical conduct and protection of human subjects.

• Demonstrated experience in managing large data sets involving clinical trials.

• Experience reading and interpreting clinical trials research protocols.

• Experience and ability to accurately collect, record, transcribe and synthesize clinical data.

• Demonstrated ability to work with large central databases.

• Demonstrated ability to display consistent accuracy with great attention to fine details.

• Possesses knowledge of medical terminology and familiarity with medical data with emphasis on HIV infection.

• Excellent organizational skills with ability to multi-task and meet ever changing priorities and timelines.

• Capacity to work efficiently in a team environment with excellent oral and written communication skills.

• Ability to coordinate specific study program actives with limited supervision, under the general direction of the Study Coordinator and Principal Investigator.

• Advanced computer skills. Expert knowledge and proficiency of Word, Excel, Access and other databases.

• Demonstrated experience interacting positively, constructively and effectively with staff, physicians, and general public.

• Ability to maintain absolute patient confidentiality and communicating verbally and in writing with staff and physicians with professionalism, sensitivity and discretion.

• Proficient at word processing, excel spreadsheets, email and with experience producing reports, profiles, correspondence, graphs and spreadsheets to generate and track required data.

• Employment is subject to a criminal background check and pre-employment physical.

• Must be willing to work with human immunodeficiency virus (HIV+), COVID, hepatitis C virus (HCV+), TB, and other infectious diseases.

• May work an occasional weekend or holiday.

• Must be willing to travel occasionally to attend national meetings.