Job Summary
The Strategies to Innovate Emergency Care Clinical Trials Network (SIREN) Clinical Coordinating Center is seeking a Project Monitor to provide monitoring support for multi-center clinical trials within the network. The Network is comprised of 90+ regional performance sites located throughout the United States. The network conducts research on various conditions that occur in the emergent care setting. The Site Monitor works closely with the members of the SIREN Clinical Coordinating Center located within the Department of Emergency Medicine at the University of Michigan. The Site Monitor collaborates with performance site activities on adherence to GCP and human subjects protection issues, data collection, data quality review and regulatory compliance. Research Coordinator experience and mastery of all job duties from the CRC-Intermediate position on the Michigan Medicine CRC Career Ladder is required. This position allows for mentoring others on study management and participating in training and development of clinical research professionals at SIREN performance sites. The Site Monitor 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 level of CRC develops new processes, procedures, tools, and training to enhance clinical research activities across the competency domains. This position continues to build on competency foundations by making greater investments in their ongoing continuing education and professional development and is an excellent career opportunity for a person currently in a CRC role. The Site Monitor behavioral competency descriptors include: Design, develop, evaluate, guide, mentor, and support.
Responsibilities*
Contribute to the development of process and tools in 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
Site Monitor Responsibilities:
- Reviewing participant screening and recruitment at performance sites
- 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, and monitor visits
- Demonstrates ability to manage increasing levels of protocol complexity and/or volume efficiently
- Trains and supports study team members at the CCC and at SIREN performance sites
- Document review and evaluation of study progress
- Various duties as needed, including yet not limited to training new SIREN team members, executing Site Manager roles and responsibilities
Study Interactions and Collection:
- Attain in-depth understanding of study protocol and objectives to assist with successful implementation of all study procedures
- Demonstrate the ability to navigate CRFs, study documents, and tools
- Demonstrate ability to identify, write and resolve complicated queries
- Review and evaluate subject visits and/or follow up interactions
- Facilitate communication between study teams and the SIREN CCC
- Prepare visit letters, monitoring reports and follow up communications.
- Track and communicate with study teams regarding subject interactions and visits
- Complete site visit documentation and follow up
- Understand specimen handling needs as applicable to a specific clinical trial
Data Entry and Cleaning:
- Assist with questions related to 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 and training on regulatory compliance
- Facilitate Independent Monitoring Committee meetings
Supervision Received:
This position reports directly to the Administrative Manager of Coordinating Center, functional supervision to trial Principal Investigators.
Supervision Exercised:
Possibly provide Functional supervision, in a limited capacity, such as training of staff in titles within the CRC Career Ladder.
Required Qualifications*
- Excellent attendance and strong work ethic in past settings
- Demonstrate ability to work successfully while meeting competing deadlines
- Excellent interpersonal skills
- Demonstrated ability to prioritize and exercise good judgement
- Proficient with eResearch
- Attention to detail and accuracy
CRC Senior:
- CRC Governance Committee review and approval.
- 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 5 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.
CRC Intermediate:
- 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*
CRC Senior:
- 9+ years of direct related experience
- Multicenter clinical trial experience
- Lab processing experience
- Survey and database creation in RedCAP, Qualtrics or MyDatahelps app.
CRC Intermediate:- 6+ years of direct related experience
- Lab processing experience
- Survey creation in RedCAP, Qualtrics or MyDatahelps app.
Work Schedule
This position will require overnight travel, although much of the monitoring can be done remotely.
Monday-Friday days although rare evenings/weekends as needed.
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.
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.
