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 Subjects Associate (CSA) will provide administrative and task oriented services assisting the Michigan Clinical Trials Support Unit (M-CTSU) research team, along with clinical research investigators. This position will be part of a clinical research staffing pool providing support to all levels of faculty and study teams for clinical trials and clinical research. The CSA will be available to assist study teams with study activities such as screening, consenting and enrolling study participants, collecting and managing participant and laboratory data, data entry, IRB application preparation, regulatory management and will assist with preparation for audits and monitor visits. This position will also provide administrative support with scheduling meetings, participant appointments, inventory management, as well as other duties as needed. The work for this role will require a combination of work days on the Ann Arbor campus and working remotely from a home location.
Demonstrates understanding of the clinical research objectives associated with the program
Demonstrates the ability to identify potential study participants
Schedules participants for research visits and follow up appointments
Maintains good rapport/communication with study participants (children and families) and study team
Able to administer minimal risk consents (simple), questionnaire and online surveys
Knows how to appropriately seek help
Demonstrates the ability to complete simple data collection during study visits
Manage study supply inventory
Assists with collection of external medical records and other documents as assigned
Attends and participates in all training classes assigned to this level
Demonstrates familiarity with essential documents as described in the ICH-Good Clinical Practice guidelines
Demonstrates the ability to understand the completion and submission of eResearch and OnCore applications
Assists in the preparation of audits, monitor visits
Working to maintain regulatory binder
This position does not provide independent study coordination
Other administrative duties as assigned
Administrative supervision is received from the M-CTSU Coordinator Manager. Functional supervision is received from the Chief Clinical Research Coordinator and Principal Investigators when applicable. This position will work in collaboration with other study team members, which may include study coordinators outside of the M-CTSU.
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
No experience 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
Good attendance record
Shift/Hours: Primarily M-F days, normal business hours.
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.
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: 193206
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.