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.
In collaboration with the Department of Pediatrics – Division of Genetics, Metabolism, & Genomic Medicine and the Children’s Clinical Trials Support Unit Clinical Research Project Manager, the Clinical Subjects Associate (CSA) will provide a value added service assisting faculty with study coordination of any clinical research within the unit as needed. This position will be part of a study coordinator pool providing support to all levels of faculty and study teams for clinical research, with special emphasis on working with children and their families. The CSA will be available to assist study teams with study activities such as screening, consenting and enrolling subjects, collecting and managing patient and laboratory data, data entry, IRB application preparation, and regulatory management. Additionally, the CSA will assist with preparation for audits and monitor visits, as well as other duties as needed. The CSA will also work closely with members of the Martin and Bielas laboratories in sample processing, DNA isolation and storage, and management of the database. This position could include travel to off-site locations.
- Identify, screen and enroll potential subjects; consent minimal risk subjects
- Collect and manage 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)
- 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
- Prepare and organize space for study related materials and equipment
- Perform DNA isolation and preparation of samples for shipment to sequencing centers
- Prepare 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
- Serve as key resource to research participants and collaborators
- Provide support for audits and monitor visits.
- High School Diploma, Associates Degree or some college, or equivalent education and experience.
- Candidates without additional experience and those who do not have a college degree should be aware that further education will be required for promotion.
- Excellent interpersonal, oral, and written communication skills with exceptional attention to detail.
- Proficient computer skills including Microsoft software applications.
- Ability to organize and manage multiple tasks simultaneously, as well as prioritize and exercise good judgment.
- Ability to work independently with minimal supervision and with diverse teams of people in a diplomatic, collaborative and effective manner.
- Good attendance record.
- Demonstrates understanding of clinical research.
- Demonstrating understanding of some medical terminology
- Experience working as a clinical research professional with children and their families.
- Knowledge of UMHS policies and practice.
- Familiarity with REDCap, OnCore, Epic, MiCHART, and eResearch applications.
- PEERS, CITI, or NIH Protection of Human Subjects Training Certification.
- Experience with local and central IRB application processes.
Evidence of qualifications is provided by previous employment, references, performance evaluations, and/or personal interview
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.
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.