Research - Laboratory/Non-Laboratory, Staff/Administrative
The Strategies to Innovate Emergency Care Clinical Trials Network (SIREN) is seeking a Project Monitor to provide monitoring support for multi-center clinical trials within the network.
The ICECAP Network is comprised of 50+ regional performance sites located throughout the United States. The network conducts research on various conditions that occur in the emergent care setting. The Project Monitor/Site Manager works closely with the members of the ICECAP Clinical Coordinating Center (ICECAP CCC) located within the Department of Emergency Medicine at the University of Michigan. The Project Monitor is responsible for ICECAP performance site activities for adherence to GCP and human subjects protection issues. Responsibilities include, but are not limited to:
Support the preparation of clinical sites for study start-up.
Conduct ongoing site monitoring visits.
Prepare and submit timely reports of visit findings and provide guidance to sites on resolution of action items.
Collaborate with ICECAP study teams on the development of case report forms, data collection tools, SOP’s, procedure manuals and study related items such as newsletters as needed.
Review the data collection processes to confirm that the clinical sites are enrolling subjects and collecting timely, accurate and complete data in compliance with the approved protocol, GCP and ICH guidelines, and ICECAP SOPs.
Review source documentation at the performance sites for adverse events, evaluating findings for seriousness, and facilitate the AE/SAE reporting process to ensure that all adverse events are reported as required.
Serve as the liaison between the clinical site(s) and the ICECAP CCC to resolve any issues that may arise throughout the course of the study.
Other responsibilities may include but are not limited to; updating and revision ofSOP’s and documents for a variety of ICECAP trial, training and orientation of ICECAP study staff, and organization of coordinator/investigator meetings.
Minimum: Bachelor's degree in health science or health related field, at least one year of clinical research monitoring, with at least two years of direct clinical research experience.
This position requires excellent written and oral communication skills. To be successful in this position the self-motivated candidate should have a working knowledge of Good Clinical Practice (GCP), as well as governmental and local regulations governing clinical research. The candidate must possess strong leadership and interpersonal skills with exceptional attention to detail. Candidates must be able to meet multiple concurrent deadlines independently. This person must demonstrate time management ability, a positive approach, and be a pro-active team member and willing to assist other teammembers as needed. Exceptional organizational skills are required.
The ideal candidate will be proficient in health/clinical research related terminology, management of regulatory documents including institutional review board (IRB) submissions, Investigational New Drug (IND) and Investigational Device Exemption (IDE) submissions to the Food and Drug Administration (FDA), research study site initiation and close out visits, study site monitoring including monitoring compliance with research regulations, adverse event reporting, investigational material accountability, quality assurance, data query resolution. A strong knowledge of 45 CFR part 46, and 21 CFR parts 50 and 56 necessary to excel in this position. Candidate must possess IT proficiency in Microsoft Word, PowerPoint, Excel, Project, and Adobe office products.
Certifications through ACRP or SoCRA are preferred but not required. Previous experience as clinical trial monitor is highly desirable.
40 Hours, Day/M-F/Flexible.
The position requires travel. It is anticipated this person will travel at least once per month/several times each year for on-site monitoring, on-site staff training, and protocol related meetings. Most of this travel can be completed in one day, although an overnight stay will usually be required. There are opportunities to accomplish some of this remotely.
The Department of Emergency Medicine at Michigan Medicine is committed to creating an environment that is welcoming to all. We strive to value the unique contributions of individuals, and support a culture of inclusivity among our employees, learners and larger community. This includes supporting the development of a diverse workforce across identities such as the race, ethnicity, national origin, sexual orientation, gender identity, age, citizenship, marital status, religion, language, disability, and Veteran status. We are proud to be an equal opportunity and an affirmative action employer.
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.
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.
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.
The University of Michigan is an equal opportunity/affirmative action employer.
Internal Number: 194466
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