Clinical Research Operations Manager

* Oversee Center Clinical Research Portfolio across the lifecycle for each protocol from feasibility, startup, recruitment, day-to-day conduct, follow up through study close out.* Ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) & all current local, state, & federal laws, regulations, guidance, policy & procedures developed by the Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH).* Develop and implement standard operating procedures (SOPs) to optimize research workflows in accordance with study sponsor, primary investigator, and regulatory specifications.* Oversee the conduct of clinical research, regulatory compliance, and IRB filings for all projects in the departmental portfolio. This includes preparing and maintaining protocol submissions and revisions.* Oversee the collection and processing of research specimens to the appropriate laboratory according to established aseptic techniques and SOPs.* Plans and coordinates research participant schedules for study procedures and study follow-up visits according to study protocol and SOPs.* Ensure research staff educate research participants about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures.* Supports data collection and analytical needs of research projects. Conducts literature reviews and helps write reports and manuscripts. Ensures project compliance with different policies, procedures, directives, and mandates.* 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), and study related communication.* Organizes and leads local operations meetings and site visits from sponsors, federal agencies, or specially designated review groups.* Oversee hiring and training of new clinical research staff.* 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.* May co-author scientific papers for presentation & publication and assist with writing, submission & administration of grants.* Accountable for all tasks in complex clinical studies.* Facilitates and participates in the daily activities of complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits. Uses in-depth knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a high degree of independence.* Performs other related work as needed.**Education:*** Advanced degree.**Experience:*** Leadership or management experience.**Preferred Competencies*** Excellent communication skills (verbal and written).* Excellent interpersonal skills.* Excellent time management and ability to prioritize work assignments.* Excellent attention to detail.* Ability to comprehend technical documents.* Ability to develop and manage interpersonal relationships.* Ability to exercise absolute discretion regarding confidential matters.* Ability to give directions.* Ability to handle sensitive matters with tact and discretion.* Ability to handle stressful situations.* Ability to perform multiple tasks simultaneously.* Ability to train or teach others.* Demonstrated knowledge of Good Clinical Practices (GCP).**Application Documents*** Resume/CV (required)* Cover Letter (required)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