Project Manager, Clinical Research

Overview

The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full-Time Project Manager, Clinical Research - Regulatory to work at the UHealth campus in Miami, FL.

Core Summary The Project Manager, Clinical Research, oversees the planning and management of clinical trials and research projects that support the overall mission of the University. The Project Manager, Clinical Research, manages the execution of regulatory-related decisions/strategies and coordinates central resource services for principal investigators and other relevant team members. The incumbent promotes clinical research by providing quality services related to research reviews, advanced assessments, research program management and educational functions, and by applying a solution-based, collaborative approach with the goal of continuous quality.

• Defines the scope of projects in conjunction with leadership and discusses the objectives and measures upon which the project will be evaluated at its completion.
• Determines the resources required to complete each project and establishes and records comprehensive project plans and timelines, which identify and sequence the activities needed to successfully complete projects.
• Reviews project schedules with leadership and other staff that will be affected by the project activities.
• Monitors the progress of the projects and makes adjustments to ensure successful completion.
• Identifies protocol problems, informs investigators of problems, or assists in problem resolution efforts such as protocol revisions.
• Consults with appropriate leadership on the selection of staff to assist with projects.
• Assigns project tasks to the identified project team for handling.
• Ensures all project personnel receive orientation that is appropriate to the project.
• Manages project staff according to the established policies and practices of the organization.
• Reviews the quality of work completed with the project team on a regular basis to ensure that work produced meets project standards.
• Documents all project-related activities and ensures project files are maintained and secured accordingly.
• Creates a communication schedule to update stakeholders, including appropriate staff in the organization on the progress of projects.
• Prepares presentations and presents status reports for leadership.
• Participates in preparation and management of research budgets and monetary disbursements and tracks items related to CDAs, budget and contract completion status.
• Adheres to University and unit-level policies and procedures and safeguards University assets.
• Oversees and provides support for the process of expanded access/compassionate use submissions (initial, annual, safety reporting) and regulatory document maintenance; serves as point of contact to internal and external stakeholders.
• Submits or assists in the submission of non-emergency and/or emergency use expanded access/compassionate use requests.
• Sends decision correspondence to appropriate parties and requests additional information as needed.
• Maintains current knowledge of applicable regulatory topics (e.g., institutional SOPs, federal regulations) and adheres to university and department-level policies and procedures while safeguarding University assets.
• Ensures compliance of expanded access/compassionate use processes with institutional SOPs, FDA, NIH, and other applicable regulations.
• Coordinates all submissions related to expanded access/compassionate use requests (single- and multi-patient) to applicable stakeholders, including but not limited to PRMC, IRB, Office of Research Administration (ORA), other departments within University of Miami/Sylvester, ancillary committees, and U.S. Food and Drug Administration (FDA).
• Oversees accurate and timely processing, tracking, and filing of submissions and other pertinent documents within institution’s electronic systems (e.g., Velos, IBIS) and appropriate drives as applicable.
• Ensures proper document management/recordkeeping for all expanded access/compassionate use projects.
• For multi-patient expanded access requests, preparation and maintenance of regulatory binders (paper or electronic) may be required.
• For multi-patient expanded access/compassionate use requests, communicates with staff to ensure the maintenance and accuracy of the Delegation of Authority Log (DOAL) when a DOAL is warranted.
• Ensures in conjunction with the DOAL that all subsequent training (whether initial or with an amendment/modification) is completed for all personnel and documentation maintained.
• Assists the Sylvester Investigator and/or staff with accurate reporting of adverse events, including those reported by expanded access/compassionate use participants in accordance with regulatory requirements.
• Supports the investigator and clinical staff with extraction of clinical data from electronic medical records and other sources to ensure proper reporting to the appropriate stakeholders.
• Provides guidance to Sylvester investigators and…