Summary

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.

Why Join Michigan Medicine?

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world’s most distinguished academic health systems.  In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 Match on retirement savings

Responsibilities*

Characteristic Duties and Responsibilities:

Knowledge of all 8 competency domains is expected:

1. Scientific Concepts and Research Design
2. Ethical Participant Safety Considerations
3. Investigational Products Development and Regulation
4. Clinical Study Operations (GCPs)
5. Study and Site Management
6. Data Management and Informatics
7. Leadership and Professionalism
8. Communication and Teamwork

This clinical research coordinator will work with a multidisciplinary team performing research to help children recover more effectively after critical illnesses. A portion of this position will involve talking with parents and health care providers to better understand how children recover after their lungs were sick enough to require the support of a lung machine called extracorporeal membrane oxygenation (ECMO). This may include the opportunity to contact families regarding the long-term outcomes of their child.

This research coordinator will partner with a Principal Investigator and Project Manager on several projects on the coordination of data collection from multiple sources, and preparation and maintenance of all regulatory materials. Other essential responsibilities include, but are not limited to:

• Collect patient and laboratory data for subjects (children) who are part of clinical research studies
• Perform data management, such as entering information into Case Report Forms (CRFs) and/or online databases
• Assist with collection of external medical records for study reporting purposes
• Work collaboratively with the Pediatric Critical Care Research team by maintaining a good rapport and communication with research team members and faculty
• Communicate with research teams outside of the University of Michigan and tracking data entry and quality
• Call and email participating families a few times a year to collect information regarding the health of their child
• Assist in the preparation of research specimens for storage and/or shipment
• Assist in the preparation of IRB amendments and scheduled continuing reviews, progress reports, safety reports and adverse event reports
• Assist in generating the information needed for IRB audits and study monitor visits
• Communicate with sponsors concerning progress of clinical research, billing calendar/budget issues, subject related problems, recruitment strategies, and specific policies and procedures

Supervision Received: This position receives direct supervision and reports directly to a CRC-Lead, CRC-Project Manager, a unit Administrator, Director, or Faculty Principal Investigator.

Supervision Exercised: None

Required Qualifications*

CRC Technician 

• Associate degree in Health Science or an equivalent combination of related education and experience is necessary
• Minimum 1 year of directly related experience in clinical research and clinical trials is necessary (Please review SoCRAs Definition of a Clinical Research Professional for qualifying experience prior to applying.) or An advanced degree in a health-related area such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD. or 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. 

CRC Assistant 

• High school diploma or GED

Both

• Excellent interpersonal, oral and written communication skills
• Attention to detail
• Proficient computer skills including Microsoft software applications
• Ability to organize/prioritize tasks effectively and efficiently
• Ability to set goals, promote teamwork and solve problems
• Good attendance record

Desired Qualifications*

CRC Technician: 

• Bachelor's degree in health science or an equivalent combination of related education and experience is desirable. 
• Experience in a large complex health care setting. 
• An understanding of medical terminology, experience in a large complex healthcare setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures. 

CRC Assistant: 

• Associate 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 healthcare setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures.

Both:

• Some understanding of clinical research
• Fluent in Spanish
• Some familiarity with REDCap, OnCore, Epic MiCHART, or eResearch applications
• Certified Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SOCRA) or Certified Clinical Research Coordinator (CCRC) through the Association of Clinical Research Professionals (ACRP)

Work Schedule

The position is full-time. The work schedule will typically be Monday-Friday, 8-hour shifts. However, flexibility on weekends and evenings may be required depending on study needs.

Underfill Statement

This position may be underfilled at the CRC-Assistant title based on selected candidates qualifications. 

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.