Director, Research Services - Military Veterans

Location: Chicago, IL
Job Description:

• Develops and executes strategic and operational plans for clinical and basic science research.
• Serves as a resource to investigators and section administrators on budgeting, contract negotiations, feasibility assessments, compliance, and best practices.
• Ensures timeliness of data and reporting submissions from multiple investigators; establishes and implements consistent standards and protocols.
• Liaises with University Research Administration, Institutional Review Board, Office of Clinical Research, Clinical Trials Financial Group, and other key constituents throughout the University.
• Supervises all pre-award and regulatory activity and staff, including the preparation of all administrative aspects of grant and contract applications in accordance with Institutional and Agency Guidelines.
• Serves as the project manager to gather all required pieces for a successful grant submission, working directly with the Principal Investigators, co-investigators, and other research staff.
• Ensures efficient operations of departmental laboratory space, including management of the basic science administrative team.
• Develops and ensures execution of activities outlined in various study plans (e.g., data management, safety management, and study communication plans).
• Demonstrates accountability for the management of assigned clinical study budgets through review of study-level scopes of work, invoices, and change orders in accordance with the evolving needs of the study.
• Drives quality efforts to proactively identify and manage risks to trial quality and ensures inspection readiness.
• Ensures that assigned clinical research coordinators deliver their projects on time, on budget, and with a high level of quality.
• Provides mentorship and supervision to the research services team. Â
• Manages and directs the protocol review process for all clinical trials which includes the receipt and coordination of protocols for review, committee meetings, and clinical research conferences.
• Plans and manages the protocol review process for all clinical trials which includes the receipt and coordination of protocols for review, committee meetings, and clinical research conferences.
• Advises the development of a formalized training program for both new and existing staff within the unit and any affiliates and/or partners. Monitors federal regulatory agency requirements related to clinical research training requirements and ensures training activities comply with requirements.
• Manages PI and other senior research faculty and personnel, participates as a skilled individual contributor and/or lead researcher as expert in specialized area. Ensures research projects progress according to plan by overseeing the coordination of the daily clinical trial activities.
• Performs other related work as needed.

Preferred Qualifications

Education:

• Advanced degree in a related field.

Experience:

• Experience managing large teams.
• Extensive experience managing complex clinical research trials for compliance/billing accuracy (e.g., site monitoring, quality assurance, create monitoring plans).
• Experience and knowledge of end-to-end management of clinical trial conduct, knowledge of the pharmaceutical industry, and clinical trials operations and regulatory requirements.

Preferred Competencies

• Excellent working knowledge of Good Clinical Practices.
• Knowledge of research regulations and medical terminology.
• Strong attention to detail.
• Ability to identify opportunities for process improvement.
• Comfortable multi-tasking in a fast-paced environment.
• Willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism.
• Effective oral, written, and interpersonal communication skills.

Application Documents

• Resume (required)
• Cover Letter (required)

The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, status as an individual with a disability, protected veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.

Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via the Applicant Inquiry Form.

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