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.
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.
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
Experience with clinical trials and/or essential documents for clinical trials
Data management experience
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.
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. 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.
The University of Michigan is an equal opportunity/affirmative action employer.
Internal Number: 182639
About University of Michigan - Ann Arbor
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.