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Clinical Research Coordinator Associate

University of Michigan

Job Description

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 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.

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

The CRC Associate or CRC Technician will be working on a clinical trial within the Department of Anesthesiology (Clinical Neuroscience Division).  For this trial, the position will conduct standardized data collection from patients 70 years of age and older, and family care partners, during in-person and phone interviews. Interviews will include cognitive assessments two times daily (including weekends) for the entire hospitalization, including extensive discharge interviews. One-month follow-up interviews with patients and family members will be conducted over the telephone.

The CR Associate or CRC Technician will conduct medical record reviews at hospital discharge and at one month to collect key study outcomes. All data collected will be entered into RedCap database in a timely manner.

This position will participate in weekly standardization meetings via zoom across sites run by the Data Core at University of Michigan.

Examples of duties a successful candidate in this role will perform:

Clinical Research Coordinator - Associate

  • Demonstrates the ability to document data in accordance with ALCOA-C principles.
  • Explains how to utilize information from the EMR and study databases.
  • Completes complex data collection during study visits.
  • Demonstrates ability to resolve data queries.
  • Demonstrates understanding of protocol elements/requirements and demonstrates the ability to execute study procedures.
  • Schedules, assists with preparation for, and attends study initiations meetings, monitor visits, and audits.

Clinical Research Coordinator - Technician

This position may independently provide study coordination for simple and moderately complex clinical research studies.  The clinical research coordinator hired for this posting will specialize in in-person interviews and standardized cognitive assessments (training provided). Mastery of all job duties from the Clinical Research Assistant position is required.

  • Completes simple to moderately complex CRFs.
  • Can resolve simple to moderately complex queries (e.g., data error changed numerous values in EDC).
  • Schedules, assists with preparation, and attends study initiation meetings, audits, and monitor visits.

 Supervision Received:This position reports directly to a CRC-Lead or CRC-Project Manager

Required Qualifications*

Clinical Research Coordinator - Associate

  • 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 Professional (CCRP) and must be achieved by 01/01/24. After 01/01/24, certification is required within six months of date of hire.
  • Minimum of 2 years directly related experience in clinical research and clinical trials is necessary.

Clinical Research Coordinator - Technician

  • Associate Degree in Health Science or an equivalent combination of related education and experience is necessary.
  • Minimum 1 year directly related experience in clinical research and clinical trials is necessary 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.

Desired Qualifications*

Clinical Research Coordinator – Associate

  • 4+ years of direct related experience.
  • 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.
  • Highly professional demeanor and positive attitude.
  • Excellent interpersonal and oral communication skills.
  • Demonstrated ability to work independently with minimal supervision.
  • Flexible weekly schedule, which will include weekends.
  • Experience working with older patient populations and their families.
  • Prior research experience involving human participants age 70 years and older is preferred.

Clinical Research Coordinator - Technician

  • 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.
  • Highly professional demeanor and positive attitude.
  • Excellent interpersonal and oral communication skills.
  • Demonstrated ability to work independently with minimal supervision.
  • Flexible weekly schedule, which will include weekends.
  • Experience working with older patient populations and their families.
  • Prior research experience involving human participants age 70 years and older is preferred.

Work Schedule

This position will be on site at University Hospital.  This position is a 40-hr/week role.  General work schedule will be 8 am – 4 pm daily and may include weekends.  Flexible weekly availability required.

Underfill Statement

This position may be underfilled at the CRC-Technician based on selected candidates’ qualifications.

Additional Information

Michigan Medicine (or unit specific name) 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 limited appointment funded through PCORI (Patient Centered Outcomes Research Initiative) through April 2027. 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.

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