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.
Prepare and organize space for study related materials and equipment to accomplish the following:
- Identify, screen and enroll potential subjects; consent minimal risk subjects
- Collect and assist in the management of patient and laboratory data for clinical research subjects
- Collect specimens and monitor study subjects (children)
- Ensure integrity of specimens (collection, processing, shipping/packing, storing, labeling, tracking, etc)
- Perform data management, such as entering information into Case Report Forms (CRFs) and internal database systems including REDCap
- Assist with collection of external medical records for study reporting purposes
- Work collaboratively with the CTSU team by maintaining a good rapport and communication with research teams and faculty, as well as patients and families
Organize schedules of the research staff; delegate duties and tasks related to the above data entry, recruitment and screening procedures.
Preparation of samples for shipment to sequencing centers.
Provide support for IRB audits and monitor visits including the following:
- Complete Regulatory duties including new study activation and processing of amendments and continuing reviews
- Assist in the preparation of IRB amendments and scheduled continuing reviews, progress reports, safety reports and adverse event reports
- In coordination with other CTSU staff, communicate with sponsors concerning progress of clinical research, billing calendar/budget issues, subject related problems, recruitment strategies, and specific policies and procedures
- Act as liaison between study team and sponsors, IRB, federal, state, and University officials and other regulatory agencies to maintain accurate communication of costs, policy changes, fiscal requirements and other regulatory issues
- Oversee and train other research staff in the research program
- Bachelor’s Degree in a relevant field of study
- Excellent interpersonal, oral, and written communication skills
- Proficient computer skills including Microsoft software applications
- Ability to organize/prioritize tasks effectively and efficiently
- Ability to set goals, promote teamwork and problem solve
- Good attendance record
- Reasonable understanding of clinical research
- Some medical terminology
- Some knowledge of UMHS policies and practice
- Some familiarity with REDCap, OnCore, Epic, MiCHART, and eResearch applications
- Some IRB/regulatory 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.
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.