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.
The Clinical Trials Support Office (CTSO) at Michigan Medicine, part of the Medical School Office of Research, has created a new model to improve clinical care, value, and health outcomes by more efficiently managing a diverse portfolio of high-quality clinical trials. Each Clinical Trial Support Unit (CTSU) provides comprehensive pre- and post-award support to study teams, and supports a group of study coordinators in each CTSU offering high-quality, efficient service in support of a mix of clinical trials.
The Clinical Research Coordinator will provide a value-added service, assisting faculty with study coordination of clinical trials. This position will be available to assist study teams with 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 Clinical Research Coordinator will manage audits and monitor visits, as well as other duties as needed. This position could include travel to off-site locations.
Things to keep in mind if you’re considering applying for this position…
-We help life-changing research happen. The science we support is not only interesting, it has the very real potential to positively impact patients and their families.
-Creative problem solving is welcomed and supported. The CTSO is a relatively new organization, and you’ll have the flexibility to impact the team as it grows its mission to support clinical research.
-We are team-oriented. You’ll have the opportunity to work with seasoned mentors, and be a part of a group that is very supportive of one another. In addition to partnering with fellow CTSO staffers, you’ll work with many different people at all levels of the University.
-We work hard, and take the time to celebrate what we achieve. There are opportunities throughout the year for employee recognition and team-building events.
Assist study teams 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. 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.
Support other clinical research staff in the CTSUs during periods of time where there is an increase in workload or for covering extended absences.
Work collaboratively with the CTSU team by maintaining a good rapport and communication with research teams and faculty, as well as patients and families.
Staff members are expected to work well in a team setting, but also independently when appropriate 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 CTSU 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 CTSU.
Bachelor’s degree in a science or health-related field, or equivalent education and experience.
Minimum of 3 years of experience as a study coordinator or study monitor.
ACRP/SoCRA certification, or effort towards certification.
Experience with the IRB application process.
Demonstrated 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.
Demonstrated understanding of some medical terminology is required.
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.
Knowledge of UMHS policies and practice.
Familiarity with Epic, MiChart and eResearch applications.
PEERRS, CITI or NIH Protection of Human Subjects Training Certification.
Proficient in sample collection/handling
Primarily M-F days, however variability will be required by some projects including early mornings, evenings 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. This job 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: 168455
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.