Assist Study Team in defining the content and format of case report forms. Recommend any data element/CRF content which may be necessitated by the design of the electronic data capture system used. Define, develop and test databases in a clinical or laboratory data management system to capture data for clinical trials. This requires creating tables, objects, and data entry screens. Write database validation rules and edit checks. Write and execute test case scenarios to successfully simulate production data entry. Resolve problems associated with database definition and case report forms (CRF). Provide a critical review and feedback of the database specification and edit checks. Able to prioritize multiple tasks within or across projects and manage time constraints with minimal direction. As required, coordinate and facilitate the CRF Development Team whose objective is to interpret the protocol and create a CRF book capturing the data used for analysis and publication of a clinical trial study. Interact with clinical, statistical, operational, data management staff and external sponsor representatives to complete required tasks. Responsible for training database associates on tasks associated with database development. Responsible for training data entry personnel on the study specific database and data entry procedures. Create and maintain appropriate documentation throughout and after implementation of the study. Establish standards and procedures for database design, data collection forms and other related tasks. Responsible for reviewing new and upgraded data management systems and data collection instrument software programs and train coworkers on the software.
Bachelor's Degree in computer or health related field and 5 years of relevant work experience in clinical research or systems configuration. Experience with relational database design and development.
Medidata Rave experience preferred. Familiarity with clinical trial experience preferred. Demonstrated clinical research forms design and build experience preferred. Proficient in Clintrial or other Clinical Database System, MS Excel, MS Word. Adobe FrameMaker - InDesign or other form design software experience desired. Personality requirements include the ability to work autonomously and on teams with minimal direction and supervision. Multi-task several projects and training at one time. Strong interpersonal skills, excellent oral and written communication skills, well organized and able to adapt to a rapidly changing environment. High attention to accuracy and detail and analytical problem solving skills required.
Education, experience and tenure may be considered along with internal equity when job offers are extended.
Monday-Friday, 8am-5pm with additional hours as necessary to complete work.
Additional hours as necessary to complete work - no set scheduled weekends.
Mayo Clinic is located in the heart of downtown Rochester, Minnesota, a vibrant, friendly city that provides a highly livable environment for more than 34,000 Mayo staff and students. The city is consistently ranked among the best places to live in the United States because of its affordable cost of living, healthy lifestyle, excellent school systems and exceptionally high quality of life.
Clinical Labs and Research
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