With limited supervision, actively participate, plan, and evaluate multiple, complex and/or multi-faceted research programs for one or more designated departments, programs, or central units. Ability to serve as principle investigator on select research projects. Duties can span a broad range of activities, or be primarily focused within one or more areas of the clinical research spectrum.
Major Job Responsibilities:
Designs, builds, validates and implements electronic data capture (EDCs) systems and eCRFs (electronic case report forms) for all investigator-initiated trials (IITs) in a variety of programs, but primarily within REDCap and the UCCI CTMS .
Develops user guides and data guidelines for use with protocol specific IIT EDCs to aid study teams in standardized data entry at UC and at other participating institutions.
Works with PIs to ensure data collection methods (CRFs/EDC) are designed to effectively collect study data for analysis and are updated as necessary throughout the lifecycle of a study.
Collaborates with statisticians and other QA team members to develop protocol-specific data management and data monitoring plans
Assists with the assessment of a project’s status, task completion, and staff productivity in order to keep study milestones on track. Determines status of incoming data, site responsiveness, need for the development of a customized action plan in order to address and prevent issues, and the need for additional support from leadership within UCCI, other UCMC departments, or within the external participating sites in order to solve outstanding issues.
Generates data retrievals and summaries and performs data analysis as needed for CTO leadership team, study Principal Investigators, and for Data Safety Monitoring Boards.
In collaboration with the study monitor, validates clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines.
Reviews electronic case report forms within an EDC for completeness and consistency. Queries data inconsistencies and revises case report forms in compliance with standard operating procedures as needed.
Reviews and implements post-production changes to active study databases in order to control study documentation and workflow.
Serves as a valuable resource to other UCMC colleagues for data management best practices and tools. May participate in committees and develop and give internal and external presentations in order to increase education and awareness of proper data management and project management techniques
Bachelor’s degree, preferably in a related discipline or equivalent education/experience.
Five (5) years relevant experience required, perferably in an academic or clinical setting.
Knowledge of clinical trials design and processes, oncology, computers, EDC systems, data management processes, forms design and development, and statistical methods preferred.
The University of Cincinnati, as a multi-national and culturally diverse university, is committed to providing an inclusive, equitable and diverse place of learning and employment. As part of a complete job application you will be asked to include a Contribution to Diversity and Inclusion statement.
As a UC employee, and an employee of an Ohio public institution, if hired you will not contribute to the federal Social Security system, other than contributions to Medicare. Instead, UC employees have the option to contribute to a state retirement plan (OPERS, STRS) or an alternative retirement plan (ARP).
The University of Cincinnati is an Affirmative Action / Equal Opportunity Employer / M / F / Veteran / Disabled.
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Internal Number: 40603-en_US
About University of Cincinnati
HISTORY IN BRIEF - The University of Cincinnati is a public urban serving research institution that was founded in 1819 and today is one of the country’s largest universities offering more than 350 academic programs to more than 44,000 students. UC has many top ranked programs in areas such as Music and Arts, Medical and Human-Services, Criminal Justice and more. Located in an urban setting, UC is close to the heart of Cincinnati and allows easy access for students to enjoy all that the city offers. UC is also the alma mater of many notables such as President William Howard Taft; Albert Sabin, developer of the oral polio vaccine; Astronaut Neil Armstrong and Mary Weinberg, 2008 Olympic gold medalist. UC is classified as a Research University (Very High Research Activity) by the Carnegie Commission and is ranked as one of America’s top 35 public research universities by the National Science Foundation. UC jumped 17 spots in the U.S. News & World Report rankings in the past two years alone. In addition to being named a “green university” by Princeton Review, UC has been named one of the world’s most beautiful campuses by Forbes and Delta Sky magazines. Learn more at www.uc.edu.MISSIO...N STATEMENT - The University of Cincinnati serves the people of Ohio, the nation, and the world as a premier, public, urban research university dedicated to undergraduate, graduate, and professional education, experience-based learning, and research. We are committed to excellence and diversity in our students, faculty, staff, and all of our activities. We provide an inclusive environment where innovation and freedom of intellectual inquiry flourish. Through scholarship, service, partnerships, and leadership, we create opportunity, develop educated and engaged citizens, enhance the economy and enrich our University, city, state and global community.