Project Manager, Clinical Research

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.

UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.

The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.

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