Clinical Research Coordinator 2 - Pediatrics

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 preterm infant and microbiome studies within the SET Center within the Department of Pediatrics. The Clinical Research Coordinator 2 works under the general direction of the PI and leadership within the Pediatric Clinical Trials Office, in accordance with established institutional policies and laboratory procedures. The CRC 2 is a specialized researcher working with the Principal Investigator (PI) and under the direction of a departmental research manager. The CRC 2 supports, facilitates and coordinates independently the daily clinical research activities and plays a critical role in the conduct of studies.
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.

• Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.

• 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.

• Performs assessments at visits and monitors for adverse events.

• May require travel to off-site clinics to meet with patients and families in follow-up clinics and as such a valid driver’s license or other ability to travel is required.

• Aliquot and prepare experimental and clinical samples for freezing.

• Ensures accurate storage for all specimen types, including fecal or microbiome samples.

• Perform experiments, collect, analyze and interpret data under the supervision of the PI or designee.

• 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.

• 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.

• 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.

• May include evening and/or weekend hours.

• Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.

• Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.

• 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 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 or relevant experience. 

• Experience coordinating multiple studies (e.g., investigator-initiated, industry-sponsored, multi-site trials). 

Preferred Competencies

• Experience with basic laboratory techniques including centrifuging, aliquoting, measuring, pipetting, labeling, storing, and shipping.

• Ability to manage multiple projects in various stages of completion.

• Ability to communicate in writing. 

• Ability to communicate orally. 

• Ability to comprehend technical documents. 

• Understanding of the federal research regulations and the ability to identify the federal research organizations’ role in regulating human research participation. 

• 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. 

• Knowledge of data analysis.

• Knowledge of Microsoft Word, Excel and Adobe Acrobat.

• Ability to work with Redcap.

• 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 train or teach others. 

• Ability to work effectively and collegially with little supervision or as member of a team. 

• Ability to work independently. 

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) 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
 

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.

 

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