Clinical Research Coordinator 2 - Pediatrics

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

Job summary

The University of Chicago seeks a Clinical Research Coordinator 2 (CRC2) in Pediatrics to provide research support under the supervision of the Director of Clinical Research and study team. The CRC2 will participate in multi-center trials, industry-supported studies, and disease-specific sections, handling data collection and regulatory processes.

The role requires robust data management, knowledge of GCP, and experience coordinating various study types.

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:---

Responsibilities

• Ensures SOPs are implemented and documented in accordance to sponsor, PI, and regulatory specifications.
• Coordinates and may participate in quality assurance reviews, including site visits and audits.
• Understands the IRB submission and review process and facilitates study initiation through IRB submissions.
• Collects, processes, ships and stores specimens per aseptic techniques.
• Prepares program conference lists for multidisciplinary conferences and workshops.
• May assist in training of new or backup coordinators.
• Accounts for all tasks in moderately complex clinical studies.
• Assists with various professional, organizational, and operational tasks under moderate supervision.
• Facilitates daily activities of moderately complex clinical studies and performs data retrieval and documentation.

Skills

Data management

Attention to detail

Medical terminology

GCP knowledge

MS Word

Excel

Adobe Acrobat

Regulatory knowledge

Education

Bachelor's degree

Job description

Department BSD PED - Clinical Trials OfficeAbout the Department

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)

Job Family

Job FamilyResearchRole ImpactIndividual ContributorScheduled Weekly Hours40Drug Test RequiredYesHealth Screen RequiredYesMotor Vehicle Record Inquiry RequiredNoPay Rate TypeSalaryFLSA StatusExemptPay 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

EligibleYesThe 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.

Posting Statement

The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, 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. 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. 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.