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Senior Clinical Research Coordinator

The University of Chicago

Job Description


Department
 

BSD MED - Section Administrator: Nephrology


About the Department
 

The Section of Nephrology at The University of Chicago is comprised of nineteen faculty members, two Ph.D. scientists, ten postdoctoral fellows as well as a staff of over 20 research, administrative and clinical personnel that are devoted to a mission of excellence in patient care, education and research. The nephrology program is ranked #23 by US News and World Report survey of best hospitals in the United States.


Job Summary
 

The Senior Clinical Research Coordinator (Sr. CRC) is a specialized researcher partnering with the clinical Principal Investigator (PI) in the Section of Nephrology in the Department of Medicine. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the Sr. CRC oversees, facilitates and coordinates the daily activities of complex clinical trials and plays a critical role in the conduct of the studies to ensure compliance with federal and institutional regulations.

Responsibilities

  • 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.

  • 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.

  • 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.

  • Performs other related work as needed.


Minimum Qualifications
 

Education:

Minimum requirements include a college or university degree in related field.

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Work Experience:

Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline.

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Certifications:

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Preferred Qualifications

Education:

  • Bachelor's degree.

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 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)



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
 

Yes


Health Screen Required
 

Yes


Motor Vehicle Record Inquiry Required
 

No


Posting Statement
 

Employees must comply with the University’s COVID-19 vaccination requirements. More information about the requirements can be found on the University of Chicago Vaccination GoForward .
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 Applicant Inquiry Form.

 

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.

 

All offers of employment are contingent upon a background check that includes a review of conviction history.  A conviction does not automatically preclude University employment.  Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.

 

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: http://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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