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Job Summary

The Pediatric Nephrology Clinical Research program is a collaborative, collegial and fast paced program that enjoys the opportunity to partner with many intramural and extramural researchers. The Research Program includes clinical trials, longitudinal cohorts, health services, and translational research with funding from a variety of sponsors including NIH, industry, and others. The patient–centered research program focuses on acute and chronic kidney diseases with an emphasis on nephrotic syndrome.

The Research Area Specialist-Associate is responsible for managing his/her assigned projects and serving as a key team member. The research team includes physicians, biostatisticians, a program manager, project managers, study coordinators, data analyst, data manager, and administrative assistant. Research trainees are added to the team on occasion.

The Research Area Specialist-Associate is expected to work independently under the guidance of the program director and supervisor.  He/she is expected to understand and support the conduct of research within all federal, state and local regulatory requirements.  Candidate participates in regulatory activities, data management, project coordination, and facilitation of research projects and proposals. Assignments may include tasks for both single-center and multi-center studies.   

 

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.

Responsibilities*

  • Coordination of activities with intramural and extramural colleagues at, but not limited to, the Food and Drug Administration [FDA], European Medicines Agency [EMA], patient advocates, and intramural and extramural physician collaborators. Specific duties include development of regulatory documents for stakeholder review and approval, input on goal setting and prioritization, generation and oversight of meeting material development.
  • Serve as lead for regulatory essential document management and oversight for multi-site clinical trials, including establishing and training to regulatory expectations, working with trial sites to collect and maintain essential documents, QC regulatory files for Trial Master File for FDA submission.
  • Support project coordination for multi-site clinical trials
  • Database development and data management and monitoring responsibilities
  • Complete data quality control checks, formatting, and cleaning
  • Develop cross-database coding and mapping systems for diagnosis, medication, and laboratory data elements
  • Scientific manuscript, abstract, poster and presentation writing/editing
  • Conduct literature search, retrieval, and summary of novel biomarkers and experimental therapeutics.
  • Communicate with the Institutional Review Board for research study approvals, amendments and continuations.

Required Qualifications*

  • Bachelor’s degree in a health or science related field
  • At least two year's work experience in a research or medical office setting
  • Demonstrated ability to work well in cross-institutional projects
  • Demonstrated excellent oral and written communication skills
  • Demonstrated attention to detail, strong interpersonal skills, and organizational skills.
  • Familiarity with medical terminology
  • Strong computer skills in Microsoft office

Desired Qualifications*

  • Experience with clinical trials and/or essential documents for clinical trials
  • Data management experience

     

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. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Application Deadline

Job openings are posted for a minimum of seven calendar days.  The review and selection process may begin as early as the eighth day after posting. This opening 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.