Associate Director, Investigator Initiated Trials

Department
BSD SUR - Research Services
About the Department
Operating since 1927 on a strong foundation of multidisciplinary clinical and academic excellence, the University of Chicago Department of Surgery’s mission is to meet the most challenging and complex health problems on both a local and global scale.
Many of our faculty members are known for their contributions to the advancement of groundbreaking surgical procedures and techniques, including minimally invasive surgery. In addition to our department’s clinical work, our scientists pursue a diverse range of basic, translational, and clinical research projects, including studies on the gut microbiome, tissue bioengineering, stem cell research, cancer, and immunotolerance.
This ongoing work and achievement would not be possible without the cohesive effort and commitment of the faculty and staff. We are looking for high energy, collaborative individuals who share our commitment to improving the health of patients in the community and beyond.
Job Summary
The role is key to leading the planning, execution, and oversight of Investigator Initiated clinical trials. In collaboration with the Executive Administrator and Vice Chair of Research, provides input into the strategic, administrative, operational, and financial decisions that impact clinical research conducted in the Department of Surgery. Works closely with the Vice Chair of Research and Principal Investigators on long-range plans for research studies. Provides leadership in facilitating the management of clinical research trials to assure sponsor expectations are met or exceeded.

Responsibilities

• Develops and ensures execution of activities outlined in various study plans (data management, safety management, and study communication plans).
• Directs research projects from initiation to completion, ensuring adherence to timelines, budgets and quality standards.
• Anticipates, recognizes, and manages issues: exhibits the ability to recognize the need to seek assistance from or inform senior management of specific risks/issues.
• Understands when decision making can occur at the study team level versus when there is a need for escalation; applies appropriate preventative and corrective actions.
• Provides leadership in process improvement activities and initiatives.
• 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.
• Synthesizes and analyzes project information and reports the outcomes.
• Mentors and supervises project managers or senior level clinical research coordinators.
• Performs quality assurance checks.
• Solves the daily administrative and technical activities in a single highly complex, large clinical trial or multiple moderately complex, concurrent clinical trials. Designs and guides internal and external audits and manages external surveys.
• Leads and implements Good Clinical Practices (GCP) and all relevant current local, state, and federal laws, regulations, policies and procedures. Develops and implements consistent standards and protocols.
• Provides expertise on the basics of clinical research and related aspects of clinical study for colleagues with less experience. Prepares and evaluates writing protocols, IRB submissions, grant applications, manuscripts, reports, and dissemination tools.
• Performs other related work as needed.

Minimum Qualifications
Education:
Minimum requirements include a college or university degree in related field.
-
Work Experience:
Minimum requirements include knowledge and skills developed through 7+ years of work experience in a related job discipline.
-
Certifications:
-
Preferred Qualifications

Education:

• Bachelor’s Degree.

Experience:

• Personnel management experience.
• 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.
• Prior experience identifying funding sources.

Preferred Competencies

• Excellent working knowledge of Good Clinical Practices.
• Knowledge of research regulations and the ability to identify the research organizations’ role in regulating human research participation.
• Knowledge of medical terminology.
• Strong attention to detail.
• Critical thinking skills for problem solving with strategic thinking capacity to drive studies.
• Ability to identify opportunities for process improvement.
• Deliver expertise to drive standardization and formulating solutions to complex issues.
• Ensure audit-ready condition of clinical trial documentation including central clinical files.
• Comfortable multi-tasking in a fast-paced environment and able to adjust workload based upon changing priorities.
• 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)

When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.
Job Family
Research
Role Impact
Individual Contributor
FLSA Status
Exempt
Pay Frequency
Monthly
Scheduled Weekly Hours
40
Benefits Eligible
Yes
Drug Test Required
No
Health Screen Required
No
Motor Vehicle Record Inquiry Required
No
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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
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We seek a diverse pool of applicants who wish to join an academic community that places the highest value on rigorous inquiry and encourages a diversity of perspectives, experiences, groups of individuals, and ideas to inform and stimulate intellectual challenge, engagement, and exchange.
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• Develops and ensures execution of activities outlined in various study plans (data management, safety management, and study communication plans).
• Directs research projects from initiation to completion, ensuring adherence to timelines, budgets and quality standards.
• Anticipates, recognizes, and manages issues: exhibits the ability to recognize the need to seek assistance from or inform senior management of specific risks/issues.
• Understands when decision making can occur at the study team level versus when there is a need for escalation; applies appropriate preventative and corrective actions.
• Provides leadership in process improvement activities and initiatives.
• 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.
• Synthesizes and analyzes project information and reports the outcomes.
• Mentors and supervises project managers or senior level clinical research coordinators.
• Performs quality assurance checks.
• Solves the daily administrative and technical activities in a single highly complex, large clinical trial or multiple moderately complex, concurrent clinical trials. Designs and guides internal and external audits and manages external surveys.
• Leads and implements Good Clinical Practices (GCP) and all relevant current local, state, and federal laws, regulations, policies and procedures. Develops and implements consistent standards and protocols.
• Provides expertise on the basics of clinical research and related aspects of clinical study for colleagues with less experience. Prepares and evaluates writing protocols, IRB submissions, grant applications, manuscripts, reports, and dissemination tools.
• Performs other related work as needed