Job Summary
The clinical research coordinator (CRC) position will provide study coordination for multiple clinical research studies of varying complexity for the Scleroderma Program in the Division of Rheumatology. We anticipate this will be 50% of the position. For other 50%, the CRC will provide oversight of the scleroderma portfolio and provide mentorship and guidance to the junior clinical research professionals on study management as well as training and development. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and mentor study team members in the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This CRC will develop new processes, procedures, tools, and training to enhance clinical research activities across the competency domains. This position continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development.
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*
Clinical Coordinator Responsibilities
The position is looking to hire a coordinator with expertise in conducting pharmaceutical-funded clinical trials.
Participant Screening and Recruitment
- Explaining study thoroughly, reviewing informed consent, answering any questions, following GCP/IRB and obtaining consent
- Demonstrates ability to triage complex study concerns appropriately
- Schedules, prepares for, and attends study initiation meetings, IMC meetings, monitor visits, and audits
- Demonstrates ability to manage increasing levels of protocol complexity and/or volume efficiently
- Collection of patient bio specimens and disease activity measures; ensure integrity of specimens (collection, processing, shipping/packing, storing, labeling, tracking, etc).
- Various duties as needed
Study Interactions and Collection
- Attain in-depth understanding of study protocol and objectives to assist with successful implementation of all study procedures
- Demonstrates the ability to create CRFs, study documents, and tools
- Demonstrates ability to resolve complicated queries
- Scheduling and completing subject visits or follow up interactions
- Preparation datasheets, questionnaires, study related documents
- Tracking and communication with study subjects
- Complete subject documentation and follow up
- Specimen handling, process lab samples, manage laboratory samples and shipping
- Submit Human Subjects Incentive Program (HSIP) requests
Data Entry and Cleaning
- Assist with data entry and capture
- Responsible for data entry and management for study
- Chart abstractions of data to enter in database(s) and source documentation
- Demonstrates ability to resolve complicated queries.
- Takes an active role in ensuring data quality.
- Review collected data and perform data quality assurance of the collected data with the study monitor
- Demonstrates expertise in data collection, data management, and results reporting.
- Various duties as needed
Regulatory
- Prepare Institutional Review Board research applications and reporting; update and maintain IRB records
- Facilitate monitoring visits on regulatory compliance
- Facilitate Independent Monitoring Committee meetings
- Add new clinical trials and update existing clinical trials at Clinicaltrials.gov.
- Working with Research Pharmacy, study medication and chain of custody
Supervisory Role
- Supervise study coordinators for upcoming and ongoing clinical trials.
- Hire and trains and supports study team members
- Facilitate communication between study teams.
- Provide guidance and study coordinators and research assistants: team leader, mentor, delegate projects and handle conflicts.
- Serve as liaison for Program Director and scleroderma clinicians.
- Develop and maintain program training and procedures
Other duties as assigned
Characteristic Duties and Responsibilities:
Set-up unit wide systems or policies and manage a team of clinical research professionals (or portfolios) in 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 reports directly to Faculty Principal Investigator.
Supervision Exercised: Could provide Functional supervision (likely in limited capacity such as training) of staff in titles within the CRC Career Ladder.
Required Qualifications*
Senior
- CRC Governance Committee review and approval
- Bachelors 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 5 years of directly related experience in clinical research and clinical trials is necessary.
Intermediate
- 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 3 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRAs Definition of a Clinical Research Professional for qualifying experience prior to applying.)
Desired Qualifications*
Senior
- 9+ years of direct related experience
Intermediate
- 6+ years of direct related experience
Work Schedule
This position will be mostly in-person with an expectation of 4-5 days per week onsite.
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.
Underfill Statement
This position may be underfilled at the CRC-Intermediate title based on selected candidates qualifications and the review and approval of the Michigan Medicine CRC Governance Board.
Additional Information
The use of this title requires approval by the University of Michigan Clinical Research Coordinator Governance Board to ensure equity in title placement across Michigan Medicine.
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.