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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.

Job Summary

As a Clinical Research Database Designer, you will become an integral part of a dynamic team that supports the world class research being done at Michigan Medicine. On a day to day basis, you will be working closely with clinical research teams to provide creative and efficient ways to take information provided in a research protocol and translate it into a working database for the storage and management of research data. Because of your detail-oriented and analytical nature, you add value by refining and clarifying the data collection and database design requirements while working in partnership with the research team. Your connection to the study team continues throughout the life of the research project. As the study continues, you may be asked to create reports, revise data collection instruments, program data quality checks, or evaluate system-based errors that occasionally arise. The nature of the research MICHR supports is diverse, which makes each project a new and interesting challenge. You will flourish in this role if you enjoy learning about clinical research protocols and helping clinical staff understand data management best practices and the concepts of database design.
 

Responsibilities*

Performs the job related expectations for this position and is competent to work on most phases of study database design and programming activities, but requires instruction and guidance in other phases.

Provide services for various stages of study database design 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:

  • Gather database requirements and develop project databases based on Standard Operating Procedures.
  • Partner with clinical research professionals to develop electronic Case Report Forms and organize data collection based on research protocols.
  • Utilize functionality within university supported Clinical Data Management Systems such as REDCap and OpenClinica to improve research data quality and improve end-user experience.
  • Program data quality checks to identify illogical or discrepant data based on requirements provided by clinical research teams.
  • Develop and program research reports to assist investigators and staff responsible for the safety of research participants, as well as the administration and evaluation of clinical research.
  • Merge multiple data sources, and extract project-specific data elements from large, relational datasets as needed.
  • Maintain research project databases and provide end-user support.
  • Perform user acceptance testing, quality control, and other forms of evaluation to inform decisions about the reliability and performance of project-specific databases or Clinical Data Management Systems.
  • Participate in the development, creation and maintenance of standardized database templates and additional tools that support the university’s research infrastructure.
  • Collaborate with Informatics and systems support staff to trouble-shoot system level problems, participate in system upgrades, and evaluate new technology.

  • Provide technical and data management expertise for special departmental projects and organizational initiatives to improve efficiency and end-user experience.

  • Contribute to the creation or delivery of presentations and/or training on database and data management topics.

Required Qualifications*

  • B.S. / B. A. degree
  • Experience (5+ years) supporting clinical research data management in a regulatory compliant environment (HIPAA, GCP, 21 CFR Part 11, etc.).
  • Experience with basic statistical analysis techniques using tools such as SAS and SPSS.
  • Experience with and knowledge of relational database design and systems development life cycle processes.
  • Programming experience (especially with SQL, MySQL, HTML) and/or experience in the support of Clinical Data Management Systems and clinical research reporting.
  • Ability to work with research team members (investigators, clinical research staff, statisticians) to determine best approach for database design and processes that support high quality data for the clinical research team.
  • Self-motivated, highly dependable, with the ability to work independently, multi-task, prioritize and solve problems Accuracy and attention to detail.
  • Strong interpersonal skills.
  • Excellent project documentation skills.
  • Demonstrated ability and experience with Microsoft Excel and Word.

Desired Qualifications*

  • Experience with OpenClinica, REDCap, OnCore platforms
  • Experience with medical coding using dictionaries such as MedDRA and WHODrug

Work Locations

NCRC B400

Background Screening

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.

Mission Statement

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.

Application Deadline

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.