Clinical Research Coordinator - Assistant at Michigan Medicine

Job 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.

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.

What Benefits can you Look Forward to?

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 Match on retirement savings
  
  
  

Responsibilities*

Characteristic Duties And Responsibilities

Independent knowledge, skills, and abilities within all 8 competency domains is expected:

• Scientific Concepts and Research Design
• Ethical Participant Safety Considerations
• Investigational Products Development and Regulation
• Clinical Study Operations (GCPs)
• Study and Site Management
• Data Management and Informatics
• Leadership and Professionalism
• Communication and Teamwork
  
  
  

Clinical Coordinator Responsibilities

Performs non-GCP related study management activities; Performs study procedures with minimal supervision; 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.)

• 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.
• 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.
• Explains the role of the Clinical Trial Support Unit (CTSU) for initiating new studies, and for subject visit billing.
  
  
  

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

Form completion 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 Reportable Information and Occurrences (ORIOs), can appropriately identify them and report them.
• 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
  
  
  

Training

Participates in trainings specifically for certification as a Clinical Research Professional

• All training requirements of previous level.
• PEERRS, HIPAA, CITI GCP
• eRPM` Regulatory training
• Attends and participates in all training assigned to this level.
  
  
  

Required Qualifications*

• High school diploma or GED is necessary.
• Experience in a medical setting
• Previous experience with subject recruitment and retention, and coordination and management of clinical trials required.
• Experience in the regulatory aspect of clinical trial management.
• Ability to work independently or as a member of a team.
• Demonstration of understanding of Medical Terminology.
• Exceptional organizational and computer skills in Microsoft software applications.
• Ability to work with minimal supervision while maintaining productivity standards.
• Demonstrated problem solving and conflict resolution skills.
• Ability to multi-task, work well under time constraints and meet deadlines.
• Excellent interpersonal, collaborative, oral and written communication skills with exceptional attention to detail and exercise of good judgement.
  
  
  

Desired Qualifications*

• 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
• Knowledge of university policies and procedures is desirable.
• Previous experience with spirometry testing and/or sputum induction desired, however on-site training is available.
• Clinical experience with respiratory patients is highly desired.
• Certification through ACRP or SOCRA.
• 3+ Years of Clinical Research Experience.
  
  
  

Work Schedule

Monday-Friday 8:00 a.m. - 5:00 p.m. (Hybrid)

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.

Additional Information

Supervision Received: This position reports directly to Faculty Principal Investigator.

Supervision Exercised: None

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.

U-M EEO Statement

The University of Michigan is an equal employment opportunity employer.