Job Description

Job Description:

• Leads within the department/unit through improving clinical research practice and serves as a resource to others.

• Works with the PIs, department, sponsors, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical studies.

• Assists with or plans and implements the clinical study's goals and objectives; organizes patient enrollment planning; conducts quality assurance activities, compiles and analyzes data.

• Acts as a liaison with medical staff, University departments, ancillary departments and/or satellite facilities.

• Serves as a resource person or acts as a consultant within area of clinical expertise.

• Acts as a leader within the department/unit through improving clinical research practice and serving as a resource.

• Maintains working knowledge of current protocols, and internal SOPs.

• Accountable for high standards of clinical research practice and assists in the development of accountability in others.

• Develops and implements procedures, maintains records, tracks progress, and conducts quality assurance on data collected.

• Oversees and participates in the coordination and conduct of complex clinical research studies and ensures compliance with federal and institutional regulations.

• Prepares, submits, and assists Investigators with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).

• Provides Investigators with guidance regarding protocol requirements.

• Maintains regulatory documentation.

• Assists other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee.

• Prepares for and assists with audits, inspections, and monitoring visits from regulatory agencies or sponsors.

• Provides direct supervision of other CRC staff (i.e. hiring/firing, performance evaluations, disciplinary actions, approve time off, etc.), or assist.

• Attends continuing education and training opportunities relevant to job duties.

• Solves complex problems relating to data management and the analysis of large administrative datasets. Works independently to develop, manage, and report on key data and ensures timeliness of data and reporting submissions from multiple investigators.

• Acts as a resource 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.

• Accountable for all tasks in complex clinical studies.

• Performs various professional, organizational, and operational tasks under limited supervision. Acts as a resource on clinical research and related aspects of clinical study for other clinical research staff. Accountable for complex problem solving on assigned clinical research studies and professional tasks.

• Performs other related work as needed.

Preferred Qualifications

Education:

• Master's degree.

Experience:

• Clinical research experience coordinating multiple and variety of studies (e.g., investigator initiated; industry sponsored; multi-site trials).

Licenses and Certifications:

• Research certification (e.g., Graham School Clinical Trials Management and Regulatory Compliance, SoCRA, ACRP).

Preferred Competencies

• Develop a program and a team.

• Excellent time management skills and ability to work independently.

• Develop research program and work strategically with Principal Investigator(s).

• Lead robust operational and financial analysis of study(ies) and/or program performance.

• Read and understand clinical trials protocols.

• Knowledge of regulatory policies and procedures.

• Strong analytical skills.

• Knowledge of grant and contract administration.

• Familiarity with medical and scientific terminology.

• Demonstrated knowledge of Good Clinical Practices (GCP).

• Identify funding sources.

Application Documents

• Resume/CV (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.

The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: securityreport.uchicago.edu. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.

About University of Chicago (UC)

One of the world's premier academic and research institutions, the University of Chicago has driven new ways of thinking since our 1890 founding. Today, UChicago is an intellectual destination that draws inspired scholars to our Hyde Park and international campuses, keeping UChicago at the nexus of ideas that challenge and change the world.

Job Tags

Similar Jobs