This position will remain open until a successful candidate has been identified.
UCSD Layoff from Career Appointment: Apply by 10/08/20 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 10/20/20. Eligible Special Selection clients should contact their Disability Counselor for assistance.
The AntiViral Research Center (AVRC) HQ develops and conducts innovative research that enhances the quality and duration of life for people living with or affected by HIV infection and other infections of global significance. The award-winning research center is an established leader in San Diego's HIV research community and is well known for its HIV testing programs. Internationally, the AVRC extends its research and education programs to Africa, Asia, and South America. Investigators from the AVRC are now leading in prevention and response efforts to the COVID-19 outbreak in San Diego County.
Under the supervision of the Corona Virus Prevention Network (CoVPN) Research Program Manager, the incumbent is responsible for all data management and quality assurance functions that will ensure timely progression and analysis of the National Institutes of Health (NIH)-funded Coronavirus (COVID-19) clinical research protocols.Incumbent will supervise a team of clinical research data associates for all COVID-19 protocols and works with cross-functional teams in designing, documenting, testing, and implementing studies in Electronic Data Capture systems, including iMedidata Rave and RedCap. Additionally, incumbent will be responsible for ensuring quality data from the El Centro site. This will include being responsible for traveling to El Centro on an occasional basis to be a resource for the data staff and provide re-training as necessary.The Clinical Research Data Manager: - Develops study specific electronic or paper Case Report Forms (CRFs), ensuring consistency with study protocol, clinical requirement, accurate, and efficient data collection; and is responsible for clinical database management, data verification, data cleaning, and quality assurance of multiple projects. - Creates and maintains data management documents per SOP (e.g. Data Management Plan, Data Validation Plan, Data Entry Guidelines, Data Transfer Agreements, etc.). - Creates and cleans edit checks to ensure data are in accordance with Good Clinical Practices (GCP) and study protocols. - Generates and resolves data queries and interfaces with study site personnel to expedite the resolution of queries and to improve the quality of data being collected. - Generates and reviews clinical medical coding for accuracy, i.e. MedDRA and WHODRUG - Prepares reports and assists with data presentations as applicable. - Validates clinical trial database on an ongoing basis for accuracy, completeness, and consistency. - Develops source documents, CRFs, Standard Operating Procedures (SOPs), study-specific SOPs, and all other documentation required for the proper conduct of a clinical trial. - Uses skills as a seasoned, experienced research professional with a full understanding of in-depth statistical analyses and/or research software programming techniques. Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
Bachelor's Degree in related area; and/or equivalent experience/training.
Two or more years of clinical data management experience.
Thorough knowledge of research function. Experience with research protocol in order to participate in the design, development and quality assurance of research data.
Thorough skills associated with statistical analysis and systems programming.
Thorough skills in analysis and consultation.
Skills to communicate complex information in a clear and concise manner both verbally and in writing.
Skills in project management.
Research skills at a level to evaluate alternate solutions and develop recommendations.
Proven ability to work with large central databases.
Demonstrated experience reading and interpreting clinical trials research protocols.
Demonstrated experience in managing large data sets involving clinical trials.
Proven experience with clinical research activities and guidelines related to consent, ethical conduct and protection of human subjects.
Capacity to work efficiently in a team environment with excellent oral and written communication skills. Experience interacting positively, constructively and effectively with staff, physicians, and general public.
UC San Diego is an academic powerhouse and economic engine, recognized as one of the top 8 public universities by U.S. News and World Report. Innovation is central to who we are and what we do. Here, students learn that knowledge isn't just acquired in the classroom - life is their laboratory. UC San Diego's rich academic portfolio includes six undergraduate colleges, five academic divisions and five graduate and professional schools. The university's award-winning scholars are experts at the forefront of their fields with an impressive track record for achieving scientific, medical and technological breakthroughs.