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.
MICHR Study Developers work closely with research teams to identify, organize, and securely store research data using various Clinical Data Management (CDM) systems and tools. Working in partnership with investigators, statisticians, and other research staff, the Study Developer must take into account the goals and objectives of these stakeholders to determine database structure, form design, variable naming conventions, validations for data quality and data reporting requirements. Study Developers must often investigate and model various design options and be able to explain the costs and benefits of each, to come up with the most effective database design.
The Study Developer ensures the database is thoroughly tested before releasing for use. Following release, the Study Developer provides user support such as: assistance with user accounts and permissions, management of database updates, creation of reports, and general troubleshooting. At the completion of a research project, the Study Developer assists with preparing the database and related documentation for archive. The Study Developer is responsible for the transfer of the final dataset to the Principal Investigator or designee at the completion of the study. Projects vary greatly in complexity and scope, and may pertain to a wide variety of research topics.
Study Developers also contribute to the development and maintenance of infrastructure at MICHR. This may include the evaluation and implementation of new electronic data capture or data management systems, testing of system upgrades, review of job-related educational materials, work processes, and Standard Operating Procedures.
Study Developers follow Standard Operating Procedures and are responsible for creating, storing, and maintaining appropriate levels of documentation.
Performs the job related expectations for this position and is competent to work on most phases of study database development and programming activities, but requires instruction and guidance in other phases. Provide services for various stages of study database projects (study initiation, ongoing study conduct and study closeout) within MICHR for research studies using available technical tools to best support the collection and management of study data.
Study database development
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.
The University of Michigan is an equal opportunity/affirmative action employer.
A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For..." survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.