Lead Clinical Research Coordinator

* Provides input into the strategic, administrative, and operational decisions that impact clinical research conducted across the University.* Assists with or plans and implements the clinical study goals and objectives; organizes patient enrollment planning; conducts quality assurance activities, compiles and analyzes data; processes blood and urine specimens.* Acts as a liaison with medical staff, University departments, ancillary departments and/or network facilities.* Collaborates with department administration on research initiatives, strategy development and clinical research oversight.* Acts as a leader within the department/unit through improving clinical research practice; serves as a resource person or acts as a consultant within area of clinical expertise.* Supervises junior staff.* Oversees financial performance of their and their team’s trial portfolio.* Conducts regulatory work in accordance with requirements for their or their team’s studies.* Maintains working knowledge of current protocols, and internal SOPs.* Accountable for high standards of clinical research practice and assists in the development of accountability in others.* Develops and implements procedures, maintains records, tracks progress, and conduct quality assurance on data collected.* Oversees and participates in the coordination and conduct of complex clinical research studies and ensures compliance with federal and institutional regulations.* Prepares, submits, and assists Investigators with multiple levels of research documentation, i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms.* Provides investigators with guidance regarding protocol requirements.* Maintains regulatory documentation.* Assists other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee.* Prepares for and assists with audits, inspections, and monitoring visits from regulatory agencies or sponsors.* Attends continuing education and training opportunities relevant to job duties.* Accountable for all tasks in highly complex clinical studies.* Oversees and participates in the daily activities of highly complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits. Uses expert knowledge of clinical research to coordinate the collection of analyzable data and/or samples with the highest degree of independence.* Performs other related work as needed.**Experience:*** Clinical research experience coordinating multiple and variety of studies (e.g., investigator initiated; industry sponsored; multi-site trials).* Previous experience managing staff.**Preferred Competencies*** Aware of safety hazards and take appropriate precautions.* Communicate in writing.* Communicate orally.* Comprehend technical documents.* Condense complicated issues to simple summaries that can be understood by a variety of constituents.* Create and deliver presentations.* Develop and manage interpersonal relationships.* Exercise absolute discretion regarding confidential matters.* Follow written and/or verbal instructions.* Give directions.* Handle sensitive matters with tact and discretion.* Handle stressful situations.* Learn and develop skills.* Maintain a high level of alertness.* Pay attention to detail.* Perform multiple tasks simultaneously.* Prioritize work and meet deadlines.* React effectively, quickly, calmly, and rationally during conflicts and emergencies.* Train or teach others.* Work effectively and collegially with little supervision or as member of a team.* Work independently.**Application Documents*** Resume (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