Project Manager, Clinical Research

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.

Responsibilities

• 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 sequences the activities needed to successfully complete projects.
• Makes adjustments to ensure successful completion of projects.
• Identifies protocol problems, informs investigators of problems, or assists in problem resolution efforts such as protocol revisions.
• Selects 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.
• 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.
• Manages research budgets and tracks items related to CDAs, budget and contract completion status.
• Adheres to University and unit-level policies and procedures and safeguards University assets.

Qualifications

• Education: Bachelor’s degree in relevant field required.
• Experience: Minimum five years of relevant experience.
• Knowledge, Skills and Attitudes: Learning Agility, Teamwork, Technical Proficiency, Communication.

Department Specific Functions

• Oversee and provide support for the process of expanded access/compassionate use submissions (initial, annual, safety reporting [as applicable]) and regulatory document maintenance; serves as point of contact to internal and external stakeholders (e.g., PI, committee(s), regulatory authorities).
• Submit or assist in the submission of non-emergency and/or emergency use expanded access/compassionate use requests.
• Send decision correspondence to appropriate parties and request additional information as needed.
• Maintain current knowledge of applicable regulatory topics (e.g., institutional SOPs, federal regulations, etc.) and adhere to university and department-level policies and procedures while safeguarding University assets.
• Safeguard compliance of expanded access/compassionate use processes with institutional SOPs, FDA, NIH, and other applicable regulations.
• Carefully coordinate 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).
• Affirmatively ensure 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.
• Affirmatively ensure proper document management/recordkeeping for all expanded access/compassionate use projects.
• For multi-patient expanded access requests, prepare and maintain regulatory binders (paper or electronic) may be required.
• Ensure in conjunction with the DOAL that all subsequent training (whether initial or with an amendment/modification) is completed for all personnel and documentation maintained.
• Assist 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.
• Support 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 (e.g., sponsor/manufacturer, IRB, FDA).
• Provide guidance to Sylvester investigators and staff related to expanded access/compassionate use requests, including but not limited to emergency use/non-emergency requests, FDA review and approval process, required committee reviews, internal workflows, etc.
• Facilitate cooperation between cross-functional teams regarding expanded access/compassionate use activities.

Benefits

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.