Job Summary
The Strategies to Innovate Emergency Care Clinical Trials Network (SIREN) Clinical Coordinating Center is seeking a Site Manager to provide project management for multi-center clinical trials within the network. The Network is comprised of 90+ performance sites located throughout the United States.
The network conducts research on various conditions that occur in the emergent care setting. The Site Manager drives and owns a sub-set of project-specific activities; compiles and presents site status updates to trial leadership; liaisons with study functional leads at the SIREN Clinical Coordinating Center located within the Department of Emergency Medicine at the University of Michigan.
The Site Manager is responsible for the overall coordination and management of regulatory and human subjects? protection across multiple sites; Accountable for project deliverables and serves as a primary study interface and point of contact for day-to-day interactions with our networks? single IRB (Advarra), leadership and sites; Tracks project progress and updated timelines and tasks as needed while keeping leadership informed of progress and changes; 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; Applies critical thinking and creative problem-solving skills in the development of new processes, procedures, tools, and training to enhance site management and other clinical research activities.
A mastery of all job duties from the Clinical Research Coordinator-Intermediate position on the Michigan Medicine Clinical Research Coordinator (CRC) Career Ladder is required. This position continues to build on competency foundations by making greater investments in their ongoing continuing education and professional development. The Site Manager behavioral competency descriptors include: lead, evaluate, develop, 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 Performance Site Management
- Data Management and Informatics
- Leadership and Professionalism
- Communication and Teamwork
Site Management Responsibilities:
- Act as liaison or point of contact between other study functional leads, site research teams, and leadership
- Responsible for leading site coordination through site initiation to site close-out
- Explaining study thoroughly, reviewing informed consent, answering any questions, following GCP/IRB requirements
- Demonstrates ability to triage complex study concerns appropriately
- Schedules, prepares for, and attends study initiation meetings
- 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 mentorship and training new SIREN team members
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 electronic case report forms (CRFs), study documents, and tools
- Facilitate communication between site study teams and the SIREN CCC
- Track and communicate cross functionally with regarding site study readiness
Data Entry and Cleaning:
- Assist with questions related to data entry and capture
- Review collected data and perform data quality assurance of the collected data with the study monitor
Regulatory:
- Prepare Institutional Review Board research applications and reporting; update and maintain IRB records over the life of the trial
Supervision Received:
This position reports directly to the Administrative Manager of the Coordinating Center, with 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*
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.
- Multicenter clinical trial project management experience
- Survey and database creation in RedCAP, Qualtrics or MyDatahelps app.
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.
- Survey creation in RedCAP, Qualtrics or MyDatahelps app.
Work Schedule
This position could require overnight travel, although minimally, once or twice annually to study investigator meetings.
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/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.