Summary

This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies depending on complexity that range from moderate to complex.  Coordinator experience and mastery of all job duties from the CRC-Technician position on the Michigan Medicine CRC Career Ladder is required.  This position should be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all 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.  Key behavioral competency descriptors include demonstrate, implement, execute, and use.

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:

Independent knowledge, skills, and abilities within 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

We are seeking an experienced and motivated clinical research professional to join our growing research program.  The Clinical Research Coordinator Associate has the general responsibility to coordinate and facilitate conduct of clinical QI processes and standards, including program design, subject recruitment and consent, data collection, compilation and analysis, database maintenance, and registry maintenance.  Compile patient list and keep up to date of patients who will be covered in upcoming population management meetings. 

Research studies will require patient recruitment, collection of bio-samples, laboratory results, and patient questionnaires. Tracking study visits and milestones and communicating with study sites will be necessary.
 

Assistance in preparation of poster and slide material for data presentation when necessary.  Coordinate division traveling to ongoing national conferences, at least once a year.  Build rapport with the physicians, principal investigators (PI's), nurses, clinical staff and other research personnel.  Coordinate QI meetings and limited patient events.  Provide administrative support for the meetings associated with the QI projects- including preparation of agendas and keeping minutes, designing and creating patient education materials in collaboration with providers, and preparing presentation materials for meetings and talks.
 

Quality improvement initiatives for Pediatric GI inflammatory bowel disease (IBD) include:
 

• Pre-visit planning for patients enrolled in the ImproveCareNow (ICN) network including- collecting forms that are completed by providers, reviewing returned forms for completeness and accuracy, publishing form return rate data monthly and quarterly, and filing forms for data collection
• Pediatric IBD population management- maintaining patient data on existing data matrix; obtaining consent for ICN registry from all IBD patient population in collaboration with the research study coordinator; creating quality reports and data request for the ICN network and the UMHS PGI medical providers
• Project liaison with the ICN network- consistent interaction with the network coordinators; reviewing and interpreting monthly data from ICN and disseminating data with the UMHS PGI providers; enrolling our Fellows for ICN QI Fundamentals sessions when applicable
• Maintaining QI IRB documents for PI's in the division; producing IBD related patient data reports by utilizing the ICN registry and through chart review in MiChart system (EPIC electronic health record system)
• While the IBD patient population is the primary focus in terms of measurable outcomes, other projects and data collection may revolve around different interests throughout the division, such as- eosinophilic esophagitis (EoE), Celiac disease, the Children's Intestinal Rehabilitation Program (ChIRP), and Pediatric Liver transplant program
   

This is a unique and important position responsible for the clinical quality improvement specific to Pediatric Gastroenterology.  This position focuses on quality and process improvement coordination of the clinical programs rather than conventional clinical research coordination.  Starting from the foundation of quality improvement in clinical care, the candidate will have the opportunity to develop in-depth and highly specialized skill set in coordinating quality improvement initiatives of the division.  As the division is engaged in an extensive effort to elevate the quality of our clinical care, we are seeking a candidate who is equally engaged in and passionate about quality improvement.   A successful candidate must be motivated to grow within the division both in breadth and depth of responsibility, comfortable with the flexibility of work schedule and location, and should possess the drive to engage and excel in a diverse variety of duties related to our quality improvement process.  Other success criteria for an ideal candidate include insight in process assessment and data analysis, ability to communicate concepts and ideas in a succinct format, personality to engage a wide spectrum of stakeholders towards a common goal, and discipline to set goals and deliver results with minimum supervision.

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.

Application material: Please enclose a cover letter as a part of the CV.

Required Qualifications*

• Highly motivated, organized, autonomous person with excellent multi-tasking ability and record-keeping skills
• Flexibility in weekly work schedule
• Computer proficiency in Microsoft applications including Word, Outlook, Excel, Power Point, and Visio
• Ability to prioritize, pay close attention to detail, follow through with tasks, and work as part of a team with medical professionals
• Professional demeanor and presentation in the office, hospital, and conferences
• Excellent verbal and written communication skills
• Ability to observe and maintain data confidentiality
• Current PEERRS, HIPAA, and University required confidentiality certification.  If not current, candidate will be required to take and pass all required PEERRS modules within six months
• Ability to work creatively while maintaining excellent organizational and interpersonal skills
• Requires contact with physicians, researchers, and other hospital personnel over the phone or in person; contact with patients over the phone or in person
• Knowledge of medical terminology
• Ability and willingness to work on-site and travel for national meetings as needed
• Must be able to work independently and as a team member while handling multiple priorities

Associate Level: 

• Bachelor's degree in Health Science including biological, social, and medical sciences or equivalent combination of related education and experience is necessary.
• Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent and must be achieved by 01/01/24.  After 01/01/24, certification is required within six months of date of hire
• Minimum 2 years of directly related experience in clinical research and clinical trials is necessary.

Technician Level: 

• 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.

or

• 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.

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.

Desired Qualifications*

• Practical experience or knowledge of the MiChart system
• Understanding of and practice experience with quality improvement and process improvement concept and methodology
• Understanding of HIPAA regulations and requirements regarding protected health information (PHI)
• Demonstrated results of improvement projects of which the candidate is an integral part
• Associate Level:
  • 4+ years of direct related experience in quality improvement, clinical trial coordination, or other patient contact experience
• Technician Level: 
  • 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

Work Schedule

The position is a 40 hour/week, full-time position (1. FTE) with on-site work requirement.  Intermittent remote work may be available as determined by the schedule. The work schedule will typically be Monday-Friday, 8-hour shifts. Occasional flexibility of work hours during work weeks and weekends will be necessary as determined by business needs.  Up to one trip per year to national meetings are required.

Underfill Statement

This position may be underfilled at the CRC-Technician title based on selected candidate's 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.

Vaccine Requirements

COVID-19 vaccinations are required for all students, faculty and staff working in the following areas: Michigan Medicine including the Medical School, Dental School, University Health Service or the Mary A. Rackham Institute.  This includes those working remotely and temporary workers.   More information on this new policy is available on the U-M Health Response.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.