Job SummaryThis 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.

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 escalate issues requiring additional intervention.

Responsibilities

• Main responsibilities and

Characteristic Duties:

Develop and maintain an understanding of study-related concepts, including research design and diabetesRecruit research participantsConduct participant outreach and communicationSchedule participant visits and complete follow-up activitiesCollect data, including through verbally administered surveysEnter and upload data and perform quality assurance checksComplete study-related documentationsCommunicate effectively with the study team, including attending weekly team meetingsPerform participant safety-related responsibilities, including distinguishing among adverse events (AEs), serious adverse events (SAEs), and other reportable information and occurrences (ORIOs), and reporting them appropriatelyWe 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:

NoneAdditional 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
• AssociateBachelor'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

• TechnicianAssociate 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

• AssistantHigh school diploma or GED is necessary. Desired Qualifications
• Clinical Research Coordinator
• Associate4+ 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

• AssistantBachelor'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 WorkPositions 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 SchedulePositions 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 ScreeningMichigan 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 StatementThe 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 StatementThe 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.

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