Job Summary
This position will serve as a Clinical Research Coordinator in the Pediatric Hematology/Oncology division, providing administrative study coordination and data entry support to faculty and research teams for the University of Michigan CS Mott Children's Hospital. Our program is renowned for our expertise in cancers like leukemia, lymphoma, and solid tumors including neuroblastoma, sarcoma and brain tumors which affect children, adolescents, and young adults. 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. As a team member, we will invest in your education, training, career development and certification.
Responsibilities*
This role will include clinical trial management of Industry and NIH Sponsored Clinical Trials (Phase II-III), and Investigator Initiated Studies. Study start-up: IRB submissions, budgeting, assist with database creation and development of study collection materials. Study Maintenance: Screen, enroll, schedule, and conduct study visits. Data collection and maintenance of eCRFs ensuring trial compliance. Regulatory Maintenance: IRB amendments and renewals, maintaining the regulatory binder and ensuring regulatory compliance. Mentoring junior coordinators in the unit.
Contribute to the development of process and tools 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
- Assist study teams with all aspects of clinical trial coordination including identifying potential subjects, screening subjects, consenting (minimal risk) and enrolling subjects, and collecting and managing patient and laboratory data for clinical research subjects
- Coordinate and facilitate correct timing of study visits and procedures with patients and clinic staff
- Coordinate the collection and integrity of research specimens (collection, processing, shipping/packing, storing, labeling, tracking, etc)
- Monitor and report abnormal or unexpected findings
- Create source documents for accurate tracking, collection, and recording of experimental data
- Utilize critical thinking skills to recognize and solve patient/participant problems including billing issues
- Work collaboratively with nurses, research pharmacy, physicians, NP's/PA's, phlebotomists and other clinical, research and administrative staff to correct/prevent protocol errors
- Expeditiously route AE and SAE information between staff, PI, and oversight agencies as appropriate
- Possibly attend investigator and scientific meetings
- Serve as a resource and contact person for active protocols
- Liaison between clinical team and research team to develop processes, troubleshoot complications and facilitate communication
- Integrate the workflow of many studies running simultaneously
- Maintain current PEERRS, or OHRP certification; knowledge and application of the Code of Federal Regulations (CFR), Good Clinical Practice (GCP), and FDA regulations, and maintain knowledge of current ICH and CFR guidelines
- Act as liaison between study team and sponsors, IRB, federal, state, and University officials and other regulatory agencies to maintain accurate communication of costs, policy changes, fiscal requirements, and other regulatory issues
- Assist in the completion of regulatory duties including new study activation and processing of amendments and continuing reviews
- Assist in the preparation of IRB amendments and scheduled continuing reviews, progress reports, safety reports and adverse event reports
- In coordination with the CTSU staff, communicate with sponsors concerning progress of clinical research, billing calendar/budget issues, subject related problems, recruitment strategies, and specific policies and procedures
Required Qualifications*
Intermediate Requirements:
- 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 SoCRA's Definition of a Clinical Research Professional for qualifying experience prior to applying.)
- High degree of comfort with smart phones, app installation, and overall technological competency
Associate Requirements:
- 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.)
- High degree of comfort with smart phones, app installation, and overall technological competency
Training Requirements:
- eRPM Regulatory training.
- Assist with training activities of staff and others.
- Attends and participate in all training assigned to this level.
Desired Qualifications*
- Master's Degree
- Reasonable understanding of clinical research
- Understanding of medical terminology related to oncology
- Some IRB/regulatory experience
- Previous experience with Epic, MiChart, eReseach, OnCore
- Excellent interpersonal, oral, and written communication skills with exceptional attention to detail.
- Excellent computer skills including proficiency in Microsoft software applications.
- Excellent organizational skills including the ability to multitask and work well under time constraints and deadlines.
- Willingness to be flexible in a dynamic working environment.
- Ability to work independently with minimal supervision and with diverse teams of people in a diplomatic, collaborative and effective manner.
- Good attendance record
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 a lower classification depending on the qualifications of the selected candidate.
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.