Research - Laboratory/Non-Laboratory, Staff/Administrative
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.
As part of the strategic research initiative, Michigan Medicine has an established model to create a new model to improve clinical care, value, and health outcomes by successfully executing a diverse portfolio of high-quality clinical trials. This model entails an organizational structure of local service CTSUs, central infrastructure, and governance oversight. CTSUs provide a professional environment of expert personnel accessible to all investigators, especially early-career faculty. The entire system is governed by the Medical School Office of Research in partnership with the Clinical Trials Subcommittee of the Research Board of Directors.
Assist with aspects of inpatient trial coordination including screening, collecting and managing patients and laboratory data for clinical research subjects.
Prepare IRB submissions including initial as well as scheduled continuing reviews, progress reports, adverse event and ORIO reports and become subject matter experts for both local and external IRB submissions.
Work collaboratively with the MCTSU finance team providing consultation on budget specifications and billing calendar creation, collaborate on post-award account reconciliation and close out.
Provide support for FDA audits.
Support other clinical research staff across the inpatient realm in study coordination activities during ‘off hours’ and weekends.
This position should be able to perform tasks independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all of their skills and abilities resulting in high quality work. It is presumed that this position is able to apply their skills to a broad range of different types of clinical studies, navigate available resources appropriately, effectively use all tools and job aids at their disposal and operate e-clinical technologies with a reasonable degree of proficiency. This position can perform the majority of tasks independently and perform quality checks of their work. They also know where and how to identify appropriate resources and support and are able to discern when to escalate issues needing additional intervention.
Functional supervision is received from the principal investigators and co-investigators. This position will work in collaboration with other study team members, including study coordinators outside of the MCTSU, along with the pre and post award finance team. Administrative supervision is received from the Assistant Director of Inpatient Research.
Bachelor degree in a science or health-related field or equivalent education and experience and over 3 years’ minimum experience as a study coordinator or study monitor.
Demonstrated knowledge of medical terminology.
Ability to work independently with minimal supervision and with diverse teams of people in a diplomatic, collaborative and effective manner.
Ability to work varied work hours. This position requires weekend work.
Excellent interpersonal, oral, and written communication skills with exceptional attention to detail.
Excellent computer skills including proficiency in Microsoft software applications.
Excellent organizational skills including the ability to multi-task and work well under time constraints and deadlines.
Experience and understanding of start-up process related to clinical trials.
Certification through ACRP or SoCRA or willingness to become certified.
Demonstrated knowledge of medical terminology specifically related to acute care.
Familiarity with UM Systems such as OnCore, MiChart (Epic) and eResearch applications.
Experience with IRB application process.
Demonstrated understanding of clinical research; understand compliance issues related to human subject research, knowledge and application of the Code of Federal Regulations (CFR), Good Clinical Practice (GCP), and FDA regulations.
PEERS, CITI or NIH Protection of Human Subjects Training Certification
This is a full time, 5-day work week, 40-hour work week position. Days of work include: Monday through Friday, Day Shift.
Variability/flexibility will be required. Ability to work both from home and on site will be required.
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.
The University of Michigan is an equal opportunity/affirmative action employer.
Internal Number: 193167
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.