Research Project Manager

Common Spirit•Phoenix, AZ

35d

About The Position

Exciting Opportunity! Join the All ALS Research Consortium as a Clinical Research Project Manager at the Barrow Neurological Institute. This is an exciting opportunity to be part of a dynamic and innovative team that collaborates with clinical sites across the United States and Puerto Rico, all united in the mission to tackle ALS, a rare and debilitating illness. In this role, you will oversee longitudinal biomarker protocols while managing diverse aspects of our research operations. Your responsibilities will include overseeing site management to ensure compliance and optimal performance, coordinating with vendors to guarantee high-quality support, and providing essential financial and grant management support. By taking on these duties, you will contribute significantly to advancing groundbreaking research that has the potential to transform lives. This position offers the chance to make a tangible impact in the ALS field while gaining new skills and working closely with a dedicated team of subject matter experts. If you are driven to contribute to innovative research and want to be part of a supportive, forward-thinking environment, we encourage you to join us on this important journey. 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.

Requirements

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

Nice To Haves

Master's Degree in related field preferred

Responsibilities

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