Clinical Research Coordinator 1 - Pediatrics | University of Chicago (UC)

Location : Chicago, IL Job Description : Coordinates 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.

Maintains accurate and complete documentation of signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.

Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules. Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.

Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and potential side effects.

Organizes and attends site visits from sponsors and other relevant study meetings. 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.

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.

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. Prepares for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.

Participates in 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. Preferred Qualifications Education : Bachelors Degree. Experience : Clinical research experience or relevant experience.

Preferred Competencies Ability to communicate in writing. Ability to communicate orally. 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 handle sensitive matters with tact and discretion. Ability to handle stressful situations. Ability to learn and develop skills.

Ability to pay attention to detail. Ability to perform multiple tasks simultaneously. Ability to prioritize work and meet deadlines.

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

Strong data management skills and attention to detail. Knowledge of Microsoft Word, Excel and Adobe Acrobat. Knowledge of data analysis.

Ability to work with Redcap. Ability to read and understand complex documents (e.g., clinical trials). Ability to handle competing demands with diplomacy and enthusiasm.

Ability to absorb large amounts of information quickly. 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) The University of Chicago is an Affirmative Action / Equal Opportunity / Disabled / Veterans Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, status as an individual with a disability, protected 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 the Applicant Inquiry Form.

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 : 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.