CommonSpirit Health Project Manager in PHOENIX, Arizona
Located conveniently in the heart ofis a 571-bed, not-for-profit hospital that provides a wide range of health, social and support services. Founded in 1895 by the Sisters of Mercy, St. Joseph's was the first hospital in the Phoenix area. More than125years later, St. Joseph's remains dedicated to its mission of caring for the poor and underserved.
We are extremely proud to be a nationally recognized center for quality quaternary care, medical education and research. St. Joseph's includes the internationally renowned,,,, and(which is verified by the American College of Surgeons). The hospital is also a respected center for high-risk obstetrics, neuro-rehabilitation, orthopedics, and other medical services.St. Joseph’s is considered a sought-after destination hospital for treating the most complex cases from throughout the world. Every day, approximately 20 percent of the hospital’s patients have traveled from outside of Arizona and the United States to seek treatment at St. Joseph’s.
U.S News & World Report routinely ranks St. Joseph's among the top hospitals in the United States for neurology and neurosurgery. In addition, St. Joseph's boasts the Creighton University School of Medicine at St. Joseph's, and a strategic alliance with Phoenix Children's Hospital.
St. Joseph's is consistently named an outstanding place to work and one of Arizona's healthiest employers. Come grow your career with one of.
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For the health of our community ... we are proud to be a tobacco-free campus.
Project Manager will be responsible for providing oversight and leadership necessary for successful delivery of pre-clinical and clinical projects from initiation to implementation to close-out of assigned research activities. The Project Manager is expected to effectively manage scope, schedule/timelines, budget, quality and resources of the assigned trial(s). Study management will also include outside clinical site management, vendor management, and study meeting planning and execution.
1.) Collaborate with project investigators and research sites to ensure targets are met for study start up, site activation, patient recruitment and enrollment
2.) Assist with clinical site contract and amendment development as applicable.
3.) Coordinate multiple studies including the review of study protocols, data and final reports
4.) Develop and collaborate on clinical documents including protocol, informed consent forms, study manuals, source documentation templates, recruitment materials and other study tools.
5.) Provides coordination and support for clinical study data management, biostatistics, and participating clinical sites.
6.) Coordinate project work activities among internal departments and stakeholders, including the biorepository and Translational Science Team.
7.) Assist in safety management and reporting to Data and Safety Monitoring Boards, medical monitors, funding and regulatory agencies.
8.) Lead cross-functional teams in the timely execution of high-quality pre-clinical and clinical research projects leveraging knowledge, expertise, and risk mitigation while functioning as the principal liaison with internal and external project stakeholders.
9.) Manage study related regulatory documents and ensure the Trial Master File (TMF) is up to date and audit ready throughout the course of the study.
10.) If applicable oversee IND and local and central IRB applications and communication with regulatory agencies (FDA,Health Canada, etc.) for studies with investigator held INDs.
11.) Assist project sites with IRB submissions, maintenance of regulatory documents and responding to study related questions from sites, vendors and sponsors in a timely fashion.
12.) Assist in database development and management, if applicable.
13.) Track key performance metrics for progress reports, help develop presentations for scientific meetings, and assist in preparing publications.
14.) Plan, manage, execute, and participate in all study team meetings both remote and in-person.
15.) Oversee quality assurance procedures for the study including the review of monitoring plans and tracking and review of trip reports.
16.) Work closely with Program Manager on project financial tracking.
17.) Take on additional tasks and responsibilities, as requested.
2 years of Project Management or 2 years of Clinical Research Experience. A combination of education and experience may be accepted.
Bachelor’s Degree in related field
Master’s Degree in related field preferred
Microsoft office package and excel experience, and Electronic Data Capture System (EDC) skill preferred
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Job ID 2020-134005
Employment Type Full Time
Department Research - ALS
Hours / Pay Period 80
Facility St Josephs Hospital and Medical Center
Standard Hours 08:00AM-05:00PM
Work Schedule 8 Hour