Cultivating a collaborative and comprehensive clinical research infrastructure that will strengthen and streamline all key areas that support individual researchers, departments, and units to enhance BSD clinical research activities and preserve academic and financial integrity;
Developing and implementing the clinical research enterprise strategy that aligns goals and objectives of the Cancer Center, Institute for Translational Medicine, Office of Clinical research, and other key stakeholders
Focusing on continuous improvement and best practices through the development of robust processes and procedures that include training, policy development, reporting, and data analytics;
Advocating for the independent Institutional Review Board (IRB): including personnel and budget management, protocol throughput, and administrative efficiency;
Provide oversight of the BSD Clinical Research Enterprise: including establishment and maintenance of institutional training standards, clinical research policies and procedures, and human resource requirements related to the clinical research community;
Overseeing the training, support, and implementation of all Clinical Research Management System(s), in conjunction with BSDIS and University Information Technology Office;
Fostering training and career development opportunities for clinical research staff.
Providing leadership for regulatory affairs administration, focused on quality systems and quality assurance support of translational and clinical research projects;
Providing leadership and support for the Research Integrity Office, including conflict of interest management programs;
Assisting with the resolution of performance issues (process, efficiency, effectiveness) related to institutional standards for human subjectâ™s research, either at the faculty level or at the clinical research unit, department, center, or institute level;
Providing leadership and support for the University of Chicago Medicine at the intersection of patient care and research, research equity, digital strategies that support clinical research, and clinical operations that facilitate safety for patients participating in research
Coordinating with other institutional leaders and Offices to represent the institution nationally and globally on matters pertaining to clinical research policy, research opportunities, and to negotiate clinical research relationships across affiliates and campuses.
Providing leadership for clinical trials coordination at UChicago network sites and other partners.
Partners with the BSD, plus UChicago Medicine & University leaders, to help establish the mission, vision, and priorities for clinical research administration across the institution
Recognized overseer of (1) the Office of Clinical Research (OCR), (2) clinical research program management & training, (3) departmental-based clinical research administration
Helps build administrative synergy, connectivity, and coordination across the clinical research enterprise
Serves as the principal clinical research administration âœambassadorâ at UC between faculty, staff, and interested external parties (sponsors, partners, & regulators)
Directs the creation of operational plans that respond to changing clinical research administration needs and regulatory demands
Liaisons with key UC offices and partners who share responsibility for clinical research success â“ e.g., compliance, URA, Provost for Research, and Deans
Manages employees through subordinates, usually other managers, to record, analyze, and report all financial transactions for clinical research trials. Evaluates potential study protocols for feasibility and cost effectiveness.
Reviews, negotiates and finalizes contractual agreements and budgets between sponsors, OCRs and other vendors. Directs the development, monitoring and reporting of project budgets and annual projections.
Performs other related work as needed.
Masterâ™s degree in research, clinical, or administration certifications (e.g., NCURA-CRA, SoCRA-CCRP, ACRP).
12 years of clinical research administration experience; or, research experience combined with relevant administrative experience.
8 years of management and/or supervisory skills (personnel and/or program management).
Experience managing clinical research projects.
Experience leading medium to large clinical research administration environments.
Be able to develop clinical research strategic plans and work collaboratively with institutional leaders and principal investigators
Be an effective listener and a skilled communicator in a faculty-driven environment, recognizing the needs of many constituent groups in many different types of operating cultures
Have experience managing large research programs such as centers, departments, and large and complex research grants
Be able to elevate the clinical research enterprise at UChicago Medicine, including a focus on faculty and staff research training;
Have interest in mentoring faculty, and creating new research opportunities through networking
Be and impactful advocate for the BSD, its faculty, and academic programs
Possess a deep understanding of budget, human resources, research operations, compliance, and other relevant clinical research management techniques and skills
Be able to lead robust operational and financial analysis of study(ies) and/or program performance
Have knowledge of regulatory policies and procedures, as well as knowledge of grant and contract administration
Possess strong analytical skills and familiarity with medical and scientific terminology
Demonstrate strong knowledge of Good Clinical Practices (GCP)
Have interpretive and applicable knowledge of computerized systems and various software packages used in clinical research administration, including Microsoft Excel, Access, and other database software programs
Be dedicated and committed to affirmative action, equal opportunity, diversity, and the highest personal integrity
Cover Letter ( preferred)
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