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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.

CORE RESPONSIBILITIES

1. 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.

2. 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.

3. Reviews project schedules with leadership and other staff that will be affected by the project activities.

4. Monitors the progress of the projects and makes adjustments to ensure successful completion.

5. Identifies protocol problems, informs investigators of problems, or assists in problem resolution efforts such as protocol revisions.

6. Consults with the appropriate leadership on the selection of staff to assist with projects.

7. Assigns project task to the identified project team for handling.

8. Ensures all project personnel receive orientation that is appropriate to the project.

9. Manages project staff according to the established policies and practices of the organization.

10. Reviews the quality of work completed with the project team on a regular basis to ensure that work produced meets project standards.

11. Documents all project-related activities and ensures project files are maintained and secured accordingly.

12. Creates a communication schedule to update stakeholders, including appropriate staff in the organization on the progress of projects.

13. Prepares presentations and presents status reports for leadership.

14. Participates in preparation and management of research budgets and monetary disbursements and tracks items related to CDAs, budget and contract completion status.

15. Adheres to University and unit-level policies and procedures and safeguards University assets.

This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.

CORE QUALIFICATIONS

Education: Bachelor's degree in relevant field required

Experience: Minimum five years of relevant experience

Knowledge, Skills and Attitudes:

• Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
• Teamwork: Ability to work collaboratively with others and contribute to a team environment.
• Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.
• Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders.

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.
• Ensure compliance of expanded access/compassionate use processes with institutional SOPs, FDA, NIH, and other applicable regulations.
• 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). Oversee 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.
• Ensure 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: communicate with staff to ensure the maintenance and accuracy of the Delegation of Authority Log (DOAL) when a DOAL is warranted.
• 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.

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

Job Status:
Full time

Employee Type:
Staff