Job Description:

• The Sr. CRC acts as a leader within the department/unit through improving clinical research practice and serves as a resource to others.
• By performing these duties, the Sr. CRC 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. other related aspects of the clinical study.
• Assist with or plan and implement the clinical study's goals and objectives; organize patient enrollment planning; conduct quality assurance activities, compile and analyze data.
• Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities.
• Serve as a resource person or act as a consultant within area of clinical expertise.
• Act as a leader within the department/unit through improving clinical research practice and serving as a resource.
• Maintain working knowledge of current protocols, and internal SOPs.
• Be accountable for high standards of clinical research practice and assist in the development of accountability in others.
• Develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected.
• Oversee and participate in the coordination and conduct of complex clinical research studies and ensure compliance with federal and institutional regulations.
• Prepare, submit, and assist Investigators with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
• Provide Investigators with guidance regarding protocol requirements.
• Maintain regulatory documentation.
• Assist other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee.
• Prepare for and assist with audits, inspections, and monitoring visits from regulatory agencies or sponsors.
• Provide direct supervision of other CRC staff (i.e. hiring/firing, performance evaluations, disciplinary actions, approve time off, etc.), or assist.
• Attend 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:

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

Preferred Competencies

• Ability to be aware of safety hazards and take appropriate precautions.
• Ability to communicate in writing.
• Ability to communicate orally.
• Ability to comprehend technical documents.
• Ability to condense complicated issues to simple summaries that can be understood by a variety of constituents.
• Ability to create and deliver presentations.
• Ability to develop and manage interpersonal relationships.
• Ability to exercise absolute discretion regarding confidential matters.
• Ability to follow written and/or verbal instructions.
• Ability to give directions.
• Ability to handle sensitive matters with tact and discretion.
• Ability to handle stressful situations.
• Ability to learn and develop skills.
• Ability to maintain a high level of alertness.
• Ability to pay attention to detail.
• Ability to perform multiple tasks simultaneously.
• Ability to prioritize work and meet deadlines.
• Ability to react effectively, quickly, calmly, and rationally during conflicts and emergencies.
• Ability to read.
• Ability to train or teach others.
• Ability to work effectively and collegially with little supervision or as member of a team.
• Ability to 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.

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