Clinical Research Coordinator 2 - Pediatrics | University of Chicago (UC)

Location : Chicago, IL Job Description : 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 drivers 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. Preferred Qualifications Education : Bachelors 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) 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.

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