Clinical Research Coordinator II

* Manages all aspects of conducting clinical trials including screening, enrollment, subject follow-up, completion of case report forms, and adverse event reports.* Coordinates 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 and data integrity.* Recruits and interviews potential study patients with guidance from PI and other clinical research staff.* Obtains informed consent.* Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.* Performs assessments at visits and monitors for adverse events.* Organizes and attends site visits from sponsors and other relevant study meetings.* Protects 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.* Understands 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.* Accountable for all tasks in moderately complex clinical studies.* Assists with various professional, organizational, and operational tasks under moderate supervision.* Performs other related work as needed.* Clinical research experience or relevant experience.* Experience coordinating multiple studies (e.g., investigator initiated, industry sponsored, multi-site trials).* Strong communication skills (verbal and written).* Excellent interpersonal skills.* Adaptability to changing working situations and work assignments.* Ability to comprehend technical documents.* 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 pay attention to detail.* Ability to perform multiple tasks simultaneously.* Excellent time management and ability to prioritize work assignments.* Ability to train or teach others.* Working knowledge of Good Clinical Practices (GCP).When applying, the document(s) **MUST** be uploaded via the **My Experience** page, in the section titled **Application Documents** of the application.The University of Chicago is an urban research university that has driven new ways of thinking since 1890. Our commitment to free and open inquiry draws inspired scholars to our global campuses, where ideas are born that challenge and change the world.We empower individuals to challenge conventional thinking in pursuit of original ideas. Students in the College develop critical, analytic, and writing skills in our rigorous, interdisciplinary core curriculum. Through graduate programs, students test their ideas with UChicago scholars, and become the next generation of leaders in academia, industry, nonprofits, and government.To learn more about the university click here #J-18808-Ljbffr