Senior Clinical Research Coordinator

Details

Posted: 19-Mar-24

Location: Chicago, Illinois

Type: Full-time

Salary: Open

Categories:

Research - Laboratory/Non-Laboratory
Staff/Administrative

Internal Number: JR25590

Location: Chicago, IL

Job Description:

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

• Works with the PI, department, sponsor, 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.

• Performs other related work as needed.

Preferred Qualifications

Experience:

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

Preferred Competencies

• Aware of safety hazards and take appropriate precautions.

• Communicate in writing.

• Communicate orally.

• Comprehend technical documents.

• Condense complicated issues to simple summaries that can be understood by a variety of constituents.

• Create and deliver presentations.

• Develop and manage interpersonal relationships.

• Exercise absolute discretion regarding confidential matters.

• Follow written and/or verbal instructions.

• Give directions.

• Handle sensitive matters with tact and discretion.

• Handle stressful situations.

• Learn and develop skills.

• Maintain a high level of alertness.

• Pay attention to detail.

• Perform multiple tasks simultaneously.

• Prioritize work and meet deadlines.

• React effectively, quickly, calmly, and rationally during conflicts and emergencies.

• Train or teach others.

• Work effectively and collegially with little supervision or as member of a team.

• Work independently.

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.

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.

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