How to Apply
A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.
- Define project requirements
- Design and develop electronic case report forms (eCRF)
- Contribute to analysis of existing data for migration to new systems
- Act as liaison between study team members to coordinate database development issues
- Support of end users on study database issues
- Manage timelines of study database development keeping study team informed of database development status and potential issues
- Manage database change requests
- Create and maintain documentation following SOPs for database development and life cycle
- Program edit/query checks for discrepant data resolution and management
- Manage PHI data during the life of the study
- Manage loading and/or storage of electronic data
- Program standard or study-specific reports for the study team
- Assist with database audits
- Prepare materials for DSMB and other study meetings
- Ensure database lock and archiving procedures are completed
- Maintenance and review of SOPs
- Assisting in estimations of work effort for budget proposals
- Participation in departmental policy review and feedback as it affects both Study Developer and interactions with other functional groups both within and outside of MICHR.
- Working with the MICHR IT support unit for creation of functional and user requirements for application enhancements and testing of system functionality during upgrade processes.
- Prepare data files for coding of adverse events and medications
- Develop standards for efficient study development
- Support the broader goals of MICHR as part of the CTSA
- Participation in MICHR sponsored activities in support of research
- Continuing education related to Clinical Trial and Clinical Data Management systems, programming and other technical areas in support of efficient data management and regulatory requirements
- Contribute to the development or implementation of educational materials, hands-on learning activities and presentations for research professionals.
- B.S. / B. A. degree
- Excellent written and verbal communication skills
- Extensive experience (5+ years) supporting clinical research data management in a regulatory compliant environment (HIPAA (privacy and security rule), GxP, 21 CFR Part 11, etc).
- Experience with basic statistical analysis techniques using tools such as SAS, SPSS.
- Experience with and knowledge of relational database design, SDLC processes and SQL.
- Ability to work with research team members (investigators, study staff, statisticians, data coordinators) to determine best approach for data base design and processes that support efficient data management for the research study team.
- Demonstrated ability and experience with Microsoft Excel and Word is required.
- Accuracy and attention to detail is required.
- Experience with Remote Electronic Data Capture (REDCap) is preferred.
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act.
Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.
Job openings are posted for a minimum of seven calendar days. This job may be removed from posting boards and filled anytime after the minimum posting period has ended.
U-M EEO/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.