Under general direction with considerable latitude for judgment and initiative; responsible for all aspects of complex day-to-day programming, management and support of the Clinical Cardiovascular Research Center (CCRC) clinical computing web service electronic data capture programs. Works closely with infrastructure staff to ensure that the associated IT systems are capable of providing high quality, efficient data processing in support of industry-supported clinical research that meets strict FDA 21CFR11 regulations. Primary customers include 30+ internal users, 250+ external web data entry users from the US and international clinical sites, multiple external core laboratory analysis centers and committee members all accessing shared clinical trial data in a multi-server and multi-study environment.
Designing and implementing a complex customized web-based clinical data collection systems utilizing the Anju suite of applications, study administration system or other web-based tools, including deployment of screens for entry of clinical data, screen automation, and data entry checks according to business specifications.
Maintaining and verifying complex web-based programs and database procedures with a strong focus toward development and implementation of finely tuned quality control measures and data cleansing applications to support extensive data analysis and publication.
Developing/implementing ad-hoc reporting tools (including web-based tools) to supplement SAS as desired by University internal and external customers
Collaborating with regulatory and infrastructure support personnel to design, implement and maintain supportable, validated quality systems.
Managing development, distribution, installation and support of custom software applications to internal and external users
Serving as backup for the configuration, maintenance and ongoing operations for CCRC’s computing assets to include all installation, configuration, operation, and routine maintenance of the software and networked servers
Facilitating expansion of clinical research at the University of Rochester through training and knowledge sharing within the CCRC group and other groups within the University as appropriate
Planning, executing, and supervising testing as well as internal and external end user training for each study specific data collection system
Keeping abreast of trends as they related to software and FDA regulatory requirements by self-study, attending job-related seminars, courses or conferences that enhance personal development and strengthens user function
Bachelor's Degree in Computer Science, Information Systems, Electrical/Electronic Engineering, Physics, Health-Related discipline or similar related fields required
Minimum of 10-15 years in application design, development, and implementation with minimum 5 years of database administration experience. Demonstrated proficiency with SQL is required. Hands-on experience with Anju clinical trials suite, RedCap or other clinical e-data capture system is strongly preferred. Prior experience managing multi-tier windows application environments strongly preferred. Knowledge of Java and Coldfusion, preferred
Experience in operating in a FDA regulated and/or validated environment (e.g. pharmaceutical, nuclear energy or financial services industry) with particular emphasis on clinical research is strongly preferred.
The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled
Pay Range: $65,000 - $135,000
The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.
Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
Opening: Full Time 40 hours Grade 055
Schedule: 8:30 AM-5 PM