Clinical Research Coordinator 2 - Pediatrics

University of Chicago; Chicago (IL); On-site; USD 60,000 - 75,000; Full time

Job summary

University of Chicago is seeking a Clinical Research Coordinator 2 (Pediatrics) to support pediatric trials in a fast-paced environment. The role involves coordinating SOPs, regulatory submissions, QA activities, and data collection across multi-site pediatric studies, under supervision.

The CRC2 will work with a PI and study team, handling specimens, training staff, and ensuring compliance with GCP and federal regulations. Onsite position in Chicago, IL.

Qualifications

• Bachelor’s degree (minimum requirement).
• 2-5 years of work experience in a related role.

Responsibilities

• Ensure SOPs are implemented and documented per sponsor, PI, and regulatory specs.
• Coordinate and participate in QA reviews, site visits, monitoring visits, audits.
• Understand IRB submission and review process and assist with IRB submissions.
• Collect, process, ship and store specimens per aseptic technique.
• Prepare conference lists for multidisciplinary conferences.
• Train new or backup coordinators as needed.
• Handle tasks in moderately complex clinical studies and assist with data/documentation.
• Contribute to data collection and sample coordination with moderate independence.

Skills

Communication

Interpersonal skills

Discretion

Time management

Data management

Medical terminology

GCP knowledge

Microsoft Word

Excel

Adobe Acrobat

Education

Bachelor’s degree (preferred)

2+ years clinical research coordination

Tools

IRB knowledge

Regulatory compliance

Job description

## Clinical Research Coordinator 2 - PediatricsApply: Onsite: Sylvain & Arma Wyler Children's Hospital: Full time: Posted Today: JR35764**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 Clinical Research Coordinator 2 (CRC2) in Pediatrics provides research support within the Department of Pediatrics. The CRC 2 works under the general direction of the Director of Clinical Research, a principal investigator (PI), and the study team. The CRC 2 will be involved in multiple research trial 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 a disease-specific Section.**Responsibilities*** Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications, ensuring compliance with federal regulations and institutional policies. Coordinates and may participate in quality assurance reviews, including site visits, monitoring visits, and audits conducted by study sponsors, federal agencies, or specially designated review groups.* 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.* Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.* Prepares program conference lists for multidisciplinary conferences and workshops.* May assist in the training of new or backup coordinators.* Accountable for all tasks in moderately complex clinical studies.* Assists with various professional, organizational, and operational tasks under moderate 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. Contributes to the problem solving on assigned clinical research studies and tasks.* Performs other related work as needed.**Minimum Qualifications****Education:**Minimum requirements include a college or university degree in related field.**Work Experience:**Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.**Certifications:****---****Preferred Qualifications****Education:** * Bachelor’s Degree.**Experience:** * 2 years of clinical research experience coordinating multiple and variety of studies (e.g., investigator-initiated; industry-sponsored; multi-site trials).**Preferred Competencies** * Ability to communicate in writing and orally; follow written and verbal instructions; comprehend and read complex technical and clinical documents.* Ability to develop and manage interpersonal relationships; work effectively, independently, or as part of a team; collaborate with faculty and divisional clinical research infrastructure; demonstrate excellent interpersonal skills.* Ability to exercise absolute discretion regarding confidential matters, sensitive, or stressful matters; handle competing demands with diplomacy and enthusiasm; maintain high alertness and respond calmly and rationally to conflicts or emergencies.* Ability to prioritize multiple tasks, manage time efficiently, meet deadlines, and maintain strong organizational skills; work independently; learn and develop new skills.* Strong data management skills and attention to detail; familiarity with medical terminology and Good Clinical Practices (GCP); extensive knowledge of Microsoft Word, Excel, and Adobe Acrobat; understanding of federal research regulations and human research protections; ability to participate in protocol review and evaluate clinical trials.**Application Documents** * Resume (required)* Cover Letter (required)The University of Chicago uses AI-assisted tools to streamline and augment some recruitment processes; however, AI is not used to make hiring decisions. 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**Scheduled** **Weekly Hours**40**Drug Test Required**Yes**Health Screen Required**Yes**Motor Vehicle Record Inquiry Required**No**Pay Rate Type**Salary **FLSA Status**Exempt **Pay Range**$60,000.00 - $75,000.00The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.**Benefits Eligible**YesThe University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.