Job Summary
This 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 Clinical Research Technician position Coordinator experience and mastery of all job duties from the CRC-Technician position on the Michigan Medicine CRC Career Ladder is requiredis 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.
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
Essential*:
30% - 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.
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.
Explains the role of the Clinical Trial Support Unit (CTSU) for initiating new studies, and for subject visit billing.
30%- 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.
30% - 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
5%- 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
5% - 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.
*Responsibilities will vary depending on unit specific needs. Some units/teams may have unique needs for proportionate focus on clinical, data, regulatory, or other needs. The CRC Associate position will support project implementation needs individually or as part of a team.
Required Qualifications*
- 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 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 prior to applying.)
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 for qualifying experience prior to applying.)
This description is intended to indicate the kinds of tasks and levels of work difficulty that will be required of positions that will be given this title and shall not be construed as declaring what the specific duties and responsibilities of any particular position shall be. It is not intended to limit or in any way modify the right of any supervisor to assign, direct, and control the work of employees under his supervision. The use of a particular expression or illustration describing duties shall not be held to exclude other duties not mentioned that are of a similar kind or level of difficulty
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
Monday-Friday 8am-5pm
This hybrid position is eligible only for in state remote work
Additional Information
This is a term-limited appointment. 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.
Additional Information
Supervision Received: This position will report directly to a Faculty Principal Investigator.
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.