Clinical Research Coordinator Associate (underfill Technician or Assistant)

Michigan Medicine; Ann Arbor (MI); On-site; USD 60,000 - 90,000; Full time

Job summary

Michigan Medicine in Ann Arbor is seeking a Clinical Research Coordinator Associate to support diabetes-focused studies within the Division of Metabolism, Endocrinology, and Diabetes (MEND). You will coordinate multiple studies, recruit participants, manage data, and ensure protocol compliance under supervision.

The role requires a Bachelor's Degree in Health Science, certification eligibility with ACRP or SOCRA within six months, and at least 2 years of clinical research experience.

Qualifications

• Bachelor's Degree in Health Science or equivalent in combined education and clinical research experience.
• Certification is required through ACRP as a Certified Clinical Research Coordinator or SOCRA as a Certified Clinical Research Professional or equivalent, eligible to register or take exam within six months of hire.
• Minimum 2 years of directly related experience in clinical research and clinical trials.

Responsibilities

• Develop and maintain understanding of study concepts, including research design and diabetes.
• Recruit research participants.
• Conduct participant outreach and communication.
• Schedule participant visits and complete follow-up activities.
• Collect data, including through verbally administered surveys.
• Enter and upload data and perform quality assurance checks.
• Complete study-related documentation.
• Communicate effectively with the study team, including attending weekly team meetings.
• Perform participant safety-related responsibilities, including reporting adverse events and other occurrences.

Skills

Digital proficiency

Communication skills

Quality assurance

Education

Bachelor's Degree in Health Science

ACRP/SOCRA certification eligibility

Job description

Job Summary

This position will serve as a Clinical Research Coordinator Associate (may be underfilled at Clinical Research Coordinator Technician or Assistant). The position is within the Division of Metabolism, Endocrinology, and Diabetes (MEND) and will provide study coordination support to University of Michigan faculty and research teams specializing in diabetes research. The Clinical Research Coordinator (CRC) may coordinate multiple clinical research studies ranging from moderate to complex.

Responsibilities

We seek candidates who can perform clinical research tasks independently, efficiently, and accurately to produce high-quality work, as well as those who are interested in mastering these skills. Given the nature of the research activities, the ideal candidate will be technologically proficient, particularly with digital, mobile, and computer-based systems, and will have flexibility in their working hours. Candidates should be able (or willing to develop the ability) to perform most tasks independently, conduct quality checks of their own work, identify and use appropriate resources and support, and recognize when to elevate issues requiring additional intervention.

Main Responsibilities And Characteristic Duties

• Develop and maintain an understanding of study-related concepts, including research design and diabetes
• Recruit research participants
• Conduct participant outreach and communication
• Schedule participant visits and complete follow-up activities
• Collect data, including through verbally administered surveys
• Enter and upload data and perform quality assurance checks
• Complete study-related documentations
• Communicate effectively with the study team, including attending weekly team meetings
• Perform participant safety-related responsibilities, including distinguishing among adverse events (AEs), serious adverse events (SAEs), and other reportable information and occurrences (ORIOs), and reporting them appropriately

We maintain high expectations for ethical conduct, professionalism, effective communication, and teamwork.

Supervision Received

This position receives direct supervision from the program manager and faculty principal investigator.

Supervision Exercised

None

Additional Expectation Based On Career Level

Clinical Research Coordinator - Associate

This position should demonstrates understanding of protocol elements/requirements and demonstrates the ability to execute study procedures.

• Demonstrates the ability to anticipate and mitigate the potential for protocol non-compliance.
• Describes protocol structure and explains how to interpret study requirements to ensure study compliance.
• Demonstrates accurate implementation of protocol procedures.
• Explains and performs non-GCP-related study management activities.
• Performs study procedures with minimal supervision.
• Triages simple subject issues appropriately.

May fill with an underfill position based on qualified candidate

Clinical Research Coordinator - Technician

This position may independently provide study coordination for simple and moderately complex clinical research studies. Mastery of all job duties from the Clinical Research Assistant position is required.

• Performs moderately complex study procedures with accuracy.
• Triages simple subject concerns appropriately.
• Assesses studies for execution and troubleshoots potential implementation issues.
• Completes simple to moderately complex data collection during study visits.
• Assists with quality control efforts.
• Performs study procedures with accuracy.
• Triages simple subject concerns appropriately.
• Assesses studies for execution and troubleshoots potential implementation issues.
• Completes simple data collection during study visits.
• Assists with quality control efforts.

Clinical Research Coordinator - Assistant

This position will assist with study coordination for simple clinical research studies.

Required Qualifications

Clinical Research Coordinator - Associate

• Bachelor's Degree in Health Science or equivalent in combined education and clinical research experience.
• 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. Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc. within six months of date of hire. (Please review eligibility criteria from SOCRA or ACRP)
• Minimum 2 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.

Underfill Qualifications

Clinical Research Coordinator - Technician

• Associate Degree in Health Science or an equivalent combination of related education and experience is necessary.
• ONE of the following:
• Minimum 1 year 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.
• High school diploma or GED is necessary.

Clinical Research Coordinator - Assistant

• High school diploma or GED is necessary.

Desired Qualifications

Clinical Research Coordinator - Associate

• 4+ years of direct related experience.
• Bachelor's Degree; Health Science field preferred or related certification.
• Understanding of medical terminology.
• Experience in a large, complex, healthcare setting.
• Ability to effectively communicate with staff and faculty of all levels.
• Knowledge of University policies and procedures.

Clinical Research Coordinator - Technician

• Bachelor's Degree; Health Science field preferred or related certification.
• Understanding of medical terminology.
• Experience in a large, complex, healthcare setting.
• Ability to effectively communicate with staff and faculty of all levels.
• Knowledge of University policies and procedures.

Clinical Research Coordinator - Assistant

• Bachelor's Degree; Health Science field preferred or related certification.
• 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.

Modes of Work

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.

Work Schedule

Positions may be eligible for hybrid work. Work agreements will be reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes. Work hours will be flexible. A combination of core business hours (Monday through Friday 9am-5pm) and weekend and evening hours will be required to support study requirements. Primary work location is at Domino's Farms in Ann Arbor.

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.

U-M EEO Statement

The University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.

U-M EEO Statement

The University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.