Job Description

This position will independently provide study coordination for simple and moderately complex clinical research studies.  As a member of the Division of Rheumatology Scleroderma Program  team, this position will support faculty with study coordination of clinical trials and observational studies with varying levels of complexity. Mastery of all job duties from the CRC-Assistant position on the Michigan Medicine CRC Career Ladder is required. 

Clinical Coordinator Responsibilities

• Performs study procedures with minimal supervision
• Schedules, assists with preparation for, and attends study initiation meetings, monitor visits, and audit
• Ensures integrity of specimen management (collection, processing, packing/shipping, storing, labeling, tracking, etc.)
• Demonstrates understanding of protocol elements/requirements and demonstrate 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 study non-GCP related study management activities.
• Performs study procedures with minimal supervision.
• Triages simple subject concerns and issues appropriately.
• Schedules, assists with preparation for, and attends study initiation meetings, monitor visits, and audits.
• Ensures integrity of specimen management (collection, processing, packing/shipping, storing, labeling, tracking, etc.).
• Comfortable with basic clinical lab equipment such as a centrifuge, various freezers, pipettes, and standard laboratory safety requirements and guidelines.

Data Coordinator Responsibilities

• Demonstrates the ability to document data in accordance with ALCOA-C principles
• Completes complex data collection during study visits; Demonstrates ability to resolve data queries
• 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.

Regulatory Coordinator Responsibilities

• Complete forms and reporting to external governing bodies such as the FDA; Demonstrating an understanding of the elements of subject safety, related documentation, and reporting;
• Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks
• Explains and performs study operational activities in compliance with Good Clinical Practice (GCP)
• Explains proper documentation techniques as outlined in the ICH-GCP guidelines.
• Explains the difference between Adverse Events (AEs), Serious Adverse Events (SAEs), and Other
• Appropriately identify and report Reportable Information and Occurrences (ORIOs)
• Works with the Office of Research Compliance Review to create and post studies in ClinicalTrials.gov and obtain the NCT.
• Demonstrates understanding of University and Federal guidelines in order to assist with Investigator Initiated studies.
• Collaborates with MIAP for INDs and IDEs.
• Demonstrates an understanding of the elements of subject safety, related documentation, and reporting. Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks.
• Demonstrates proficiency in all eResearch applications and submissions, such as continuing renewals and amendments.
• Demonstrates ability to maintain essential regulatory documents as outlined in the ICH-GCP guidelines.
• Maintenance of updated regulatory documentation.
• Explain the investigational products development process and identify key regulations to control these processes

Administrative Responsibilities

• Provide other administrative support for study activity including management of subject reimbursement and payments
• May assist with creating posters, abstracts, and articles
• Participates in regular study meetings. Properly completes payment forms and pays participants accordingly

Other Responsibilities: Additional duties as otherwise assigned by supervisor(s). 

Experience as part of a team with 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

Supervision Received: This position receives direct supervision and reports directly to the Faculty Principal Investigator.

Supervision Exercised: None.

Technician:

• 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. (Please review SoCRA?s Definition of a Clinical Research Professional for qualifying experience prior to applying.)  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.  
• PEERRS, HIPAA, CITI GCP Training eRPM Regulatory training
• Attends and participates in all training assigned to this level.

Assistant:

• High school diploma or GED is necessary. 

Technician:

• Bachelors 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.

Assistant:

• Associate 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. 

This position will be onsite 5 days per week. 

This position may be underfilled at the CRC-Assistant title based on selected candidates? qualifications.

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.

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.

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.

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.

The University of Michigan is an equal employment opportunity employer.

About University of Michigan - Ann Arbor

A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.

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