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 Children’s Clinical Trials Support Unit Medical Directors, Administrator, and Clinical Research Project Manager, the Clinical Subjects Coordinator (CSC) will provide a value added service assisting faculty with study coordination of any clinical trials 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 trials, with special emphasis on working with children and their families. The CSC will be available to assist study teams with study coordinator 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 CSC will assist with preparation for audits and monitor visits, as well as other duties as needed. This position could include travel to off-site locations and/or subject home visits.
Assist study team with aspects of clinical trial coordination including: identifying potential subjects, screening subjects, consenting and enrolling subjects, and collecting and managing patient and laboratory data for clinical research subjects.
Collect specimens and monitor study subjects (generally working with children and families). Assist in monitoring of test results. Ensure integrity of specimens (collection, processing, shipping/packing, storing, labeling, tracking, etc.).
Perform data management and results reporting, such as entering information into Case Report Forms (CRFs). Assist with collection of external medical records for study reporting purposes. Ability to identify and report Adverse Events (AEs) and Serious Adverse Events (SAEs).
Prepare IRB submissions including the initial applications, as well as 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 trials, 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.
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.
Staff members are expected to work independently and regularly exercise good judgment in setting priorities, resolving operational problems, and applying policies, procedures, and methods, while maintaining the strictest of confidentiality at all times.
Administrative supervision is received from the Clinical Research Project Manager. Functional supervision is received from principal investigators. This position will work in collaboration with other study team members, which may include study coordinators outside of the Clinical Trials Support Units.
Bachelor’s degree in a science or health-related field, or equivalent education and experience.
Demonstrates understanding of clinical research; understand compliance issues related to human subjects research, knowledge and application of the Code of Federal Regulations (CFR), Good Clinical Practice (GCP), and FDA regulations.
Demonstrating understanding of some medical terminology is required.
Proficient in specimen collection.
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.
ACRP or SoCRA certification, or effort towards certification.
2-4 years of experience as a study coordinator or study monitor.
Experience working as a study coordinator with children and their families.
Knowledge of Michigan Medicine policies and practice.
Familiarity with OnCore, Epic, MiCHART, and eResearch applications.
PEERS, CITI, or NIH Protection of Human Subjects Training Certification.
Experience with local and central IRB application processes.
Shift/Hours: Primarily M-F days, however variability may be required by some projects including early mornings, evenings, nights, weekends and occasional travel.
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.
The University of Michigan is an equal opportunity/affirmative action employer.
Internal Number: 172958
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.