OverviewHello humankindness (https://hellohumankindness.org/)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 Barrow Neurological Institute (https://www.barrowneuro.org/) , Norton Thoracic Institute (https://www.dignityhealth.org/arizona/norton-thoracic-institute) , Cancer Center at St. Joseph's (https://www.dignityhealth.org/arizona/locations/stjosephs/services/university-of-arizona-cancer-center) , Ivy Brain Tumor Center (https://www.ivybraintumorcenter.org/) , and St. Joseph's Level I Trauma Center (https://www.supportstjosephs.org/traumacenter) (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 Arizona's Most Admired Companies (http://www.bestcompaniesaz.com/) .Look for us on Facebook (http://www.facebook.com/DignityHealthStJosephsHospitalMedicalCenter) and follow us on Twitter (https://twitter.com/DignityHealthAZ) .ResponsibilitiesExciting Opportunity! Join the Gregory W. Fulton ALS and Neuromuscular Disease Center as a Clinical Research Project Manager! We're expanding our team for a groundbreaking initiative within a new ALS research consortium funded by the NIH. As a key player you'll oversee multi-center clinical studies in ALS contributing to cutting-edge research and making a significant impact on the future of ALS studies. This role offers a unique chance for Research Project Managers to elevate their careers grow professionally and be part of a transformative journey in neuromuscular disorder research. Multiple openings available for passionate individuals ready to shape the future of ALS research!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.
Collaborate with project investigators and research sites to ensure targets are met for study start up site activation patient recruitment and enrollment
Assist with clinical site contract and amendment development as applicable
Coordinate preclinical project work activities among internal departments and stakeholders including the Pre-clinical Pharmacokinetic and Pharmacodynamic Core and Senior Scientists
Coordinate multiple studies including the review of study protocols data and final reports
Ensure compliance with pre-clinical guidelines
Work with biorepository and veterinary managers to ensure that materials for pre clinical study work are available and provided
Provides coordination and support for clinical study data management biostatistics and participating clinical sites.
Assist in safety management and reporting to Data and Safety Monitoring Boards medical monitors funding and regulatory agencies.
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
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
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
QualificationsEducation and Experience:
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
Microsoft office package and excel experience and Electronic Data Capture System (EDC) skill preferred
Preferred:
Master’s Degree in related field preferred
Pay Range$30.55 - $44.30 /hourWe are an equal opportunity/affirmative action employer.