Job Information
University of Michigan Clinical Research Coord Inter in Ann Arbor, Michigan
Clinical Research Coord Inter
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How to Apply
A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.
Summary
A Clinical Research Coordinator is needed to coordinate multiple clinical studies related to cirrhosis. The main focus is a randomized trial of lactulose and tai chi to prevent falls among people with cirrhosis. We are also conducting trials of transitional care after discharge from the hospital. This position will independently provide study coordination for complex clinical research studies. 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. They also know where and how to identify appropriate resources and support and are able to discern when to escalate issues needing additional intervention. The team includes one PI, a project manager, and four other research coordinators. The environment is collegial and everyone is invested in each others career development and well-being. Key behavioral competency descriptors include demonstrate, implement, execute, and use. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity.
This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties from the CRC-Associate position on theMichigan Medicine CRC Career Ladder (https://research.medicine.umich.edu/our-units/clinical-trials-support-office/clinical-research-coordinator-career-ladder) is required. This position should begin to serve on various clinical research committees at the University level. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and demonstrate the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This position contributes to the development of new processes, procedures, and tools to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on their work. This level of CRC continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development. Key behavioral competency descriptors include: Design, demonstrate, develop, guide, and support.
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*
Expert level 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:
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.
Set-up TeleTai-Chi intervention for participants across all LIVE-SMART sites.
Coordinate TeleTai-Chi classes for instructors, schedule sessions, track participant attendance, and troubleshoot and assist participants and instructors as needed during classes.
Ensure participants are able to safely participate in TeleTai-Chi classes, in conjunction with instructors.
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. Troubleshoot technological problems that arise during Tai-Chi classes. May require direct contact with participant.
Schedules, assists with preparation for, and attends study initiation meetings, monitor visits, and audits.
Data Coordinator Responsibilities:
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.
Creates and completes simple to moderately complex CRFs.
Regulatory Coordinator Responsibilities:
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.
Demonstrates understanding of University and Federal guidelines in order to assist with Investigator Initiated studies.
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:
May assist with creating posters, abstracts, and articles.
Will communicate with study participants such as sending study correspondence via mail or email.
Will schedule subjects for Tai-Chi classes.
Will check study calendar for completion of study procedures.
Will utilize documents and systems to track participation in Tai0Chi classes and retention of participants.
Maintain proper study documentation (safety reporting, Note to Files)
Participates in regular study meetings. Properly completes payment forms and pays participants accordingly
Training:
All training requirements of previous level.
PEERRS, HIPAA, CITI GCP
eRPM` Regulatory training
Attends and participates in all training assigned to this level.
Gains appropriate training & knowledge of EMR, CTMS, EDC, databases, etc. as assigned.
Willing to learn and use available technology and systems to accomplish job requirements.
Understands the disease process per program.
Supervision Received: This position reports direct to the CRC-Project Manager.
Supervision Exercised: Could provide functional supervision (likely in a limited capacity such as training) of staff in titles within the CRC Career Ladder.
Required Qualifications*
Bachelor's degree in Health Science or an equivalent combination of related education and 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 3 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.
Desired Qualifications*
6+ years of direct related experience
Experience working in clinical research or patient settings is a plus
Experience working in, or knowledge of, IT or technical assistance is a plus
Work Schedule
Work schedule is Monday to Friday. Full time preferred, part-time eligible
Additional Information
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.
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/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.
Job Detail
Job Opening ID
247806
Working Title
Clinical Research Coord Inter
Job Title
Clinical Research Coord Inter
Work Location
Ann Arbor Campus
Ann Arbor, MI
Full/Part Time
Full-Time
Regular/Temporary
Regular
FLSA Status
Exempt
Organizational Group
Medical School
Department
MM Int Med-Gastroenterology
Posting Begin/End Date
4/17/2024 - 5/01/2024
Career Interest
Research
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