Clinical Research Coordinator 2 - Pediatrics

University of Chicago; Berlin; Vor Ort; EUR 52.000 - 65.000; Vollzeit

Zusammenfassung

The University of Chicago in the BSD PED - Clinical Trials Office is seeking a Clinical Research Coordinator 2 (CRC2) in Pediatrics to support multidisciplinary research efforts, including national and multi-site trials. You will work under the Director of Clinical Research and a study team to coordinate operations, data collection, and regulatory tasks.

Minimum qualifications include a college degree and 2–5 years of clinical research experience; strong data management skills, knowledge of GCP,

Qualifikationen

• Bachelor’s Degree (required).
• 2–5 years of clinical research experience.
• Knowledge of Good Clinical Practices (GCP).
• Strong data management and documentation skills.

Aufgaben

• Ensure SOPs are followed and documentation updated per sponsor and regulatory specs.
• Understand IRB submission processes and facilitate study initiation.
• Coordinate specimen handling and storage per protocol.
• Prepare conference lists for multidisciplinary meetings.
• Train and support new coordinators.

Kenntnisse

Communication

Data management

Attention to detail

GCP familiarity

Ausbildung

Bachelor’s Degree

Tools

Microsoft Word

Excel

Adobe Acrobat

Jobbeschreibung

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 accordancetostudy sponsor, primary investigator, and regulatory agency specifications, ensuring compliance with federal regulations and institutional policies.Coordinates and mayparticipatein 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 andtimelypreparation of IRB submissions independently.

• Collect, process,shipand store specimens toappropriate laboratoryaccording toestablishedaseptic techniques.

• Prepares program conference lists for multidisciplinary conferences and workshops.

• Mayassistin the training of new or backup coordinators.

• Accountable for all tasks in moderately complex clinical studies.

• Assistswith various professional, organizational, and operational tasks under moderate supervision.

• Facilitates andparticipatesin 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; comprehendand 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; demonstrateexcellent interpersonal skills.

• Ability to exercise absolute discretionregardingconfidential matters, sensitive, or stressful matters; handle competing demands with diplomacy and enthusiasm; maintainhigh alertness and respond calmly and rationally to conflicts or emergencies.

• Ability to prioritize multiple tasks, manage time efficiently, meet deadlines, andmaintainstrong 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 toparticipatein protocol review and evaluate clinical trials.

Application Documents

• Resume (required)
• Cover Letter (required)

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 - $75,000.00

The 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

Yes

The 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 safe­ 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.