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University of Chicago Senior Clinical Research Coordinator in Chicago, Illinois

Please make sure to read the job posting in its entirety as it reflects both the University roles and responsibilities, followed by the specific description.
Department

2012220 Medicine-Emergency Medicine

About the Unit

In existence for over thirty years, the Section of Emergency Medicine is comprised of 27 full–time and 14 part-time faculty members, as well as an outstanding staff of research, administrative and clinical personnel who are devoted to the mission of excellence in patient care, education and research. The Emergency Medicine faculty cover and maintain the staffing and operation of the adult emergency department (ED) at The University of Chicago Medicine. In December 2017, the Section began treating patients in its new, state-of-the art adult ED.

Job Family

Research

Responsible for all aspects of research projects and research facilities. Plans and conducts clinical and non-clinical research; facilitates and monitors daily activities of clinical trials or research projects. Directs engineering and technical support activities to develop and maintain tools and computational methods needed to gather and analyze data.

Career Track and Job Level

Clinical Research

Manages, facilitates, and monitors the daily activities of clinical research and clinical trials. Performs a variety of duties involved in the collection, documentation, analysis and reporting of clinical research and clinical trial data. Manages the strategic, administrative, operational, and financial decisions that impact clinical research and clinical trials conducted across the University.

P3: Requires in-depth knowledge and experience. Uses best practices and knowledge of internal or external University issues to improve products or services. Solves complex problems; takes a new perspective using existing solutions. Works independently, receives minimal guidance. Acts as a resource for colleagues with less experience.

Role Impact

Individual Contributor

Responsibilities

The job independently manages the collection, documentation, analysis of clinical trial data, and reporting of clinical research data. Provides input into the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University.

1) Manages the daily administrative and technical activities in a single highly complex, large clinical trial or multiple moderately complex, concurrent clinical trials. Designs and guides internal and external audits and manages external surveys., 2) 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., 3) 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., 4) 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., 5) Performs other related work as needed.

Unit-specific Responsibilities

1) The Senior Clinical Research Coordinator (Sr. CRC) is a specialized researcher partnering with the clinical Principal Investigator (PI).

2) 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.

3) The Sr. CRC acts as a leader within the department/unit through improving clinical research practice and serves as a resource to others.

4) 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. 5) 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.

6) Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities.

7) Serve as a resource person or act as a consultant within area of clinical expertise.

8) Act as a leader within the department/unit through improving clinical research practice and serving as a resource.

9) Maintain working knowledge of current protocols, and internal SOPs.

10) Be accountable for high standards of clinical research practice and assist in the development of accountability in others.

11) Develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected.

12) Oversee and participate in the coordination and conduct of complex clinical research studies and ensure compliance with federal and institutional regulations.

13) Prepare, submit, and assist Investigators with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).

14) Provide Investigators with guidance regarding protocol requirements.

15) Maintain regulatory documentation.

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

17) Prepare for and assist with audits, inspections, and monitoring visits from regulatory agencies or sponsors.

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

19) Attend continuing education and training opportunities relevant to job duties.

20) Extended hours including evenings, nights and weekends may be required at times.

Unit-preferred Competencies

1) Ability to train junior CRCs.

2) Ability to participate in protocol review and clinical trials evaluations.

3) Excellent interpersonal skills.

4) Strong data management skills and attention to detail.

5) Ability to handle competing demands with diplomacy and enthusiasm.

6) Ability to work collaboratively with faculty and divisional clinical research infrastructure.

7) Excellent time management and ability to prioritize work assignments.

8) Ability to read and understand clinical trials protocols.

9) Familiarity with medical terminology/environment.

10) Working knowledge of Good Clinical Practices (GCP).

11) Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat.

Education, Experience, and Certifications

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

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

Preferred Qualifications

Education

1) Bachelor's degree

Experience

1) 5 years of clinical research experience coordinating multiple and variety of studies (e.g., investigator initiated; industry sponsored; multi-site trials).

Required Documents

1) Resume

2) Cover letter

Note:When applying, all required documents MUSTbe uploaded under the Resume/CV section of the application.

FLSA Status

Exempt

Pay Frequency

Monthly

Pay Grade

Depends on Qualifications

Scheduled Weekly Hours

40

Benefits Eligible

Yes

Drug Test Required

Yes

Health Screen Required

Yes

Motor Vehicle Record Inquiry Required

No

Posting Date

2019-10-17-07:00

Remove from Posting On or Before

2020-04-17-07:00

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.

  • Posted 30+ Days Ago
  • Full time
  • JR06829
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