Clinical Research Coordinator 2 - Pediatrics
The University of Chicago

Job Info

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Department

BSD PED - Clinical Trials Office

About the Department

In the Department of Pediatrics at the University of Chicago, we strive to provide the highest level of complex care for children from diagnosis and treatment to conducting research to find promising new therapies with a focus on teaching. We are committed to advancing the frontiers of knowledge, and the education and training of future clinical pediatricians, subspecialists, educators, clinical investigators and physician-scientists. The Department of Pediatrics is a dynamic, stimulating place to work, and because we are focused on growth and improved excellence, our staff have particularly challenging and rewarding roles.

The Pediatric Clinical Trials Office (Peds CTO) is an existing centralized support office that provides services and high level guidance to individuals (faculty, investigators, research staff, and clinic coordinators from the University and Hospital) involved in human subjects research. The Peds CTO is responsible for establishing standards, operating procedures, policies and practices, implementing educational and training programs, developing communication tools, and managing the administrative functions that impact individuals involved in clinical research.

Job Summary

The Pediatric Clinical Research Coordinator (CRC) 2 provides support to the Section of Rheumatology within the Department of Pediatrics. The CRC2 will be involved in multiple research trials types: multi-centered cooperative group and intergroup studies at a national level, multi-institutional pharmaceutical trials, and multi-centered trials designed, implemented and coordinated in the Section. The Clinical Research Coordinator 2 works under the general direction of the PI and leadership within the Pediatric Clinical Trials Office.

Our department follows a hybrid work structure that fosters productivity, collaboration, and employee well-being. Working from the office is encouraged for tasks that require a high degree of collaboration.

Responsibilities

• Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
  
• Recruit and interview potential study patients with guidance from PI and other clinical research staff.
  
• Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.
  
• Identify and explain the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
  
• Coordinate the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.
  
• Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.
  
• Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures.
  
• Performs assessments at visits and monitors for adverse events.
  
• Organizes and attends site visits from sponsors and other relevant study meetings.
  
• Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.
  
• Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.
  
• Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.
  
• Understand the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions independently.
  
• Ensures compliance with federal regulations and institutional policies.
  
• May prepare and maintain protocol submissions and revisions.
  
• May assist in the training of new or backup coordinators.
  
• Assists with and performs various administrative and operational tasks under moderate to limited supervision.
  
• Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.
  
• Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a limited to moderate degree of independence. Contribute to the problem-solving on assigned clinical research studies and tasks.
  
• Analyzes, facilitates and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research charts, and participation in program audits.
  
• Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study.
  
• 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 2-5 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:

• Direct patient contact experience.
  
• Experience coordinating multiple studies (e.g., investigator-initiated, industry-sponsored, multi-site trials).
  
• Experience using electronic medical records systems (EMR).
  

Technical Skills and Knowledge:

• Strong data management skills.
  
• Knowledge of Microsoft Office and Adobe Acrobat.
  

Preferred Competencies

• Absorb large amounts of information quickly.
  
• Adaptability to changing working situations and work assignments.
  
• Attention to detail.
  
• Interact and communicate (verbal and written) with clarity, tact, and courtesy with patrons, patients, staff, faculty, students and others.
  
• Read and understand technical documents.
  
• Time management and task prioritization.
  
• Modeling ethical and compliant conduct of clinical research.
  
• Recognize and analyze issues requiring resolution.
  
• Understanding of the federal research regulations and the ability to identify the federal research organizations' role in regulating human research participation.
  
• Exercise absolute discretion regarding confidential matters.
  
• Follow written and/or verbal instructions and give direction to others.
  
• Handle sensitive matters with tact and discretion, including stressful situations.
  
• Ability to maintain a high level of alertness and perform multiple tasks simultaneously.
  
• React effectively, quickly, calmly, and rationally during conflicts and emergencies.
  
• Ability to train or teach others.
  

Working Conditions

• Eligible for hybrid work based on business needs and the demands of specific tasks. Working from the office is encouraged for tasks that require a high degree of collaboration.
  

Application Documents

• Resume (required)
  
• Cover Letter (required)
  

When applying, the document(s) MUSTbe 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

The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, national or ethnic origin, age, status as an individual with a disability, military or 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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