Job Summary
The central aspect of this role will be coordinating and facilitating clinical research, including but not limited to subject recruitment, regulatory submissions, data analysis/manuscript preparation, and maintaining databases for multi-site registries. Training related to research ethics, human subject protections, clinical study design, and data analytics and statistical methodology will be provided. The CRC will have opportunities to co-author medical journal submissions and will be encouraged to present results at regional and national meetings. We are a seeking responsible, motivated, and independent individual who will be completing or has completed an advanced degree in health-related areas and can commit a minimum of 2 gap years between college and medical/graduate school.
This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the CRC-Assistant position on the Michigan Medicine CRC Career Ladder is required.
Mission Statement
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.
Responsibilities*
Experience as part of a team with all 8 competency domains is expected:
Scientific Concepts and Research Design
Ethical Participant Safety Considerations
Investigational Products Development and Regulation
Clinical Study Operations (GCPs)
Study and Site Management
Data Management and Informatics
Leadership and Professionalism
Communication and Teamwork
Additional Responsibilities:
Perform moderately complex study procedures with accuracy.
Recruit, screen, and obtain consent for potential research subjects for studies within the department.
Support in-person and remote consenting, enrollment, and follow-up tasks as needed and requested by participants and the study team.
Collect, enter, and manage data.
Triage simple subject concerns and issues appropriately.
Assess studies for execution and troubleshoot potential implementation issues.
Schedule, assist with preparation, and attend study initiation meetings, audits, and monitor visits.
May work with CTSUs to reconcile financial accounts for study participants.
Assist with local quality control efforts.
May create recruitment plans that address the needs of the study population and develop materials for IRB submissions that will aid in recruitment.
Assist in preparing for internal and external audits and reports, such as regulatory compliance and sponsor milestones.
Required Qualifications*
Excellent organizational skills and attention to detail.
Superb interpersonal skills ? comfortable speaking with healthcare providers, research sponsors, and patients.
Ability to communicate effectively and professionally in both verbal and written form.
Ability to work independently but also within a team.
Ability to prioritize multiple tasks and meet deadlines are a must.
Technician:
Associate degree in Health Science or an equivalent combination of related education and experience.
ONE of the following:
Minimum 1 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying.
An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD.
Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research.
Assistant:
High school diploma or GED is necessary.
Desired Qualifications*
Bachelor's degree in Health Science or an equivalent combination of related education and experience is desirable.
An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable.
Able to commit to a minimum of 2 years.
Work Schedule
This a full-time regular position, M-F, standard 8-hour work day. Onsite work is required.
Underfill Statement
This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.
Additional Information
Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe.
Background Screening
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.
Application Deadline
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.
U-M EEO/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.