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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 (ICECAP CCC) 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*
25% – Clinical Coordinator Responsibilities
50% – Data Coordinator Responsibilities
5% – Administrative Responsibilities
15% – Training – Provides mentorship of other clinical research staff; maintains certification
*Responsibilities will vary depending on unit specific needs. Some units/teams may have unique needs for proportionate focus on clinical, data, regulatory, or other needs. The CRC Senior position should take on all leadership responsibility except direct administrative supervision of staff.
SUPERVISION RECEIVED This position reports directly to the SIREN Administrative Director (Administratively) and SIREN CCC and trial Principal Investigators (Functionally)
SUPERVISION EXCERCISED Could provide functional supervision (likely in limited capacity such as training) of staff in the role of Clinical Research Assistant, Clinical Research Technician, CRC Associate, or CRC Intermediate.
Required Qualifications*
CRC SENIOR
CRC INTERMEDIATE
Desired Qualifications*
Work Schedule
This position will require overnight travel, although much of the monitoring can be done remotely. Monday-Friday days are the standard working hours although rare evenings/weekends as needed.
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 Boar
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 Department of Emergency 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. This description is intended to indicate the kinds of tasks and levels of work difficulty that will be required of positions that will be given this title and shall not be construed as declaring what the specific duties and responsibilities of any particular position shall be. It is not intended to limit or in any way modify the right of any supervisor to assign, direct, and control the work of employees under his supervision. The use of a particular expression or illustration describing duties shall not be held to exclude other duties not mentioned that are of a similar kind or level of dfficulty.
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.
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