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Senior Clinical Research Coordinator

Job description



Hyde Park Campus

Department
2012212 Medicine-Cardiology

About the Unit

Job Information

Job Summary:

The Senior Clinical Research Coordinator (Sr CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of clinical trials, 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. 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/section, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical studies.

Responsibilities:

Research Conduct/Study Management:

  • 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.


Data Management:
  • Develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected.


Regulatory:
  • 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.

Competencies:
  • Ability to train junior CRCs required.
  • Ability to participate in protocol review and clinical trials evaluations required.
  • Excellent interpersonal skills required.
  • Strong data management skills and attention to detail required.
  • Ability to handle competing demands with diplomacy and enthusiasm required.
  • Ability to work collaboratively with faculty and divisional clinical research infrastructure required.
  • Excellent time management and ability to prioritize work assignments required.
  • Ability to read and understand clinical trials protocols required.
  • Familiarity with medical terminology/environment required.
  • Working knowledge of Good Clinical Practices (GCP) required.
  • Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat required.


Additional Requirements

Education and Experience:
  • Bachelor's degree required.
  • Minimum of 5 years of clinical research experience coordinating multiple and variety of studies (e.g., investigator initiated; industry sponsored; multi-site trials) required.
  • Experience coordinating multiple and a variety of studies (e.g., investigator initiated, industry sponsored, multi-site trials) required.


Required Documents:
  • Resume
  • Cover Letter

NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application

Benefit Eligibility
Yes

Pay Frequency
Monthly

Pay Range
Depends on Qualifications

Scheduled Weekly Hours
40

Union
Non-Union

Job is Exempt?
Yes

Drug Test Required?
Yes

Does this position require incumbent to operate a vehicle on the job?
No

Health Screen Required?
Yes

Posting Date
2018-12-05-08:00

Remove from Posting On or Before
2019-06-05-07:00

Posting Statement:

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.

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.

Full time
JR03589

About Us
The University of Chicago is an urban research university that has driven new ways of thinking since 1890. Our commitment to free and open inquiry draws inspired scholars to our global campuses, where ideas are born that challenge and change the world.

We empower individuals to challenge conventional thinking in pursuit of original ideas. Students in the College develop critical, analytic, and writing skills in our rigorous, interdisciplinary core curriculum. Through graduate programs, students test their ideas with UChicago scholars, and become the next generation of leaders in academia, industry, nonprofits, and government.

To learn more about the university click here http://www.uchicago.edu/

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Job No:
Posted: 12/6/2018
Application Due: 2/4/2019
Work Type:
Salary: