How to Apply

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.

Summary

This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties from the CRC-Intermediate position on the Michigan Medicine CRC Career Ladder is required. This position should begin to serve on various clinical research committees at the University level. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and demonstrate the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This position contributes to the development of new processes, procedures, and tools to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on their work. This level of CRC continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development. Key behavioral competency descriptors include: Design, demonstrate, develop, guide, and support.

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.

Responsibilities*

Characteristic Duties and Responsibilities:

Expert level 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

Clinical Coordinator Responsibilities

• Participant Screening and Recruitment
• Reviewing real time medical records to match potential research participants with inclusion/exclusion criteria for active studies
• Explaining study thoroughly, reviewing informed consent, answering any questions, following GCP/IRB and obtaining consent
• Demonstrates ability to triage complex study concerns appropriately
• Schedules, prepares for, and attends study initiation meetings, monitor visits, and audits
• Demonstrates ability to manage increasing levels of protocol complexity and/or volume efficiently
• Various duties as needed

Study Interactions and Collection

• Attain in-depth understanding of study protocol and objectives to assist with successful implementation of all study procedures
• Demonstrates the ability to create CRFs, study documents, and tools
• Demonstrates ability to resolve complicated queries
• Scheduling subject visits or follow up interactions
• Facilitate communication between clinic/unit staff and study teams.
• Knowledge with spirometry and sputum collection or the willingness to be trained.
• Preparation datasheets, questionnaires, study related documents
• Tracking and communication with study subjects
• Complete subject documentation and follow up in online system 
• Specimen handling, process lab samples, manage laboratory samples and shipping

Data Entry and Cleaning

• Assist with data entry and capture
• Demonstrates the ability to create CRFs, study documents, and tools.
• Responsible for data entry and management for study
• Chart abstractions of data to enter in database(s) and source documentation
• Demonstrates ability to resolve complicated queries.
• Takes an active role in ensuring data quality.
• Review collected data and perform data quality assurance of the collected data with the study monitor
• Demonstrates expertise in data collection, data management, and results reporting.
• Various duties as needed

Regulatory

• Prepare Institutional Review Board research applications and reporting
• Provides logistic and regulation guidance on Investigator Initiated Studies for adherence to University and Federal guidelines

Supervision Received: This position reports directly to CRC-Project Manager.

Supervision Exercised: Could provide Functional supervision (likely in limited capacity such as training) of staff in titles within the CRC Career Ladder.

Required Qualifications*

• Bachelor's degree in Health Science or an 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) and must be achieved by 01/01/24.  After 01/01/24, certification is required within six months of date of hire. 
• Minimum 3 years of directly related experience in clinical research and clinical trials is necessary. 

Desired Qualifications*

• 6+ years of direct related experience

Work Schedule

Monday - Friday, 8:00am - 5:00pm (hybrid)

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. 

This is a one year term-limited appointment with the possibility of extension. Extension will be based on the availability of funding and performance. At the end of the stated term, your appointment will terminate, and will not be eligible for Reduction-in-Force (RIF) benefits.  This term-limited appointment does not create a contract or guarantee of employment for any period of time as you will remain subject to disciplinary or other performance measures, up to and including termination, at the will of the University in accordance with existing University policy and standards for employee performance and conduct.

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.