Clinical Research Coordinator I

Department BSD NSU - Research About the Department Neurosurgeons at UChicago Medicine are devoted to patient care, research, and teaching. These experts in the Department of Neurological Surgery offer the full spectrum of neurosurgical services for children and adults with brain diseases including aggressive brain tumors, back and spine degenerative diseases, epilepsy, Parkinsons disease, and stroke. Our surgeons are truly at the forefront of neurosurgical care, utilizing the most advanced and sophisticated technologies and techniques to treat diseases of the brain and spine. Our expertise goes beyond that of delivering the best medical care; research is an integral part of our mission. With significant funding from the NIH in both bench and translational research, our staff and faculty are actively investigating complex conditions that affect the central nervous system, including cancer stem cell theory and aggressive brain cancers as well as the mechanisms behind cerebrovascular anomalies. This work serves as the groundwork for many new applications in neurosurgery, which will benefit patients for many years to come. Job Summary This position performs routine assignments related to the documentation, analysis, and reporting of research data. Provides input to support the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the Department of Neurological Surgery. Responsibilities Manages all aspects of conducting clinical trials and clinical research studies from startup to closeout for clinical trials. Responsibilities include, but are not limited to, recruitment and screening of study subjects, obtaining informed consent, enrollment of subject in research study, subject follow-up, collecting and analyzing research data, completion of the case report form (CRF), adverse event reports and ensuring protocol adherence. Plans and coordinates subjects schedules for study procedures, return visits, and study treatment schedules; educates subjects about study procedures to be performed, what to report between and during visits, and the risks and benefits of the procedures; performs assessments at visits and monitors for adverse events. Collects, processes, ships, and stores specimens to appropriate laboratory according to established aseptic techniques. Independently performs assessments to monitor for and identify adverse events and protocol deviations or violations, and assists PI in reporting to the sponsor and IRB under general direction of department, clinical research manager and/or the Office of Clinical Research. Organizes and actively participates in site visits from sponsors and other relevant study meetings. Maintains a safe research environment and ensures compliance with governmental and University policies, procedures and regulations. Controls the acquisition/collection, abstraction, processing, privacy, and quality assurance for all clinical research data required for the protocol. Responsibilities include, but are not limited to, provides efficient and complete data collection, processing, analysis and reporting; assures source documentation and data abstraction and entry are being done at the protocol specified time-points; ensures data accuracy and integrity by working closely with internal monitors and/or auditors to promptly resolve any data quality concerns or outstanding queries; and facilitates the exchange of data across projects and organizations. Protects patient and data confidentiality by ensuring security of research data and protected health information (PHI) and compliance with federal regulations and sponsor protocols. Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, PI, and regulatory agency specifications. Maintains accurate and complete records which may include, but are not limited to, signed informed consent, Institutional Review Board (IRB) communication, source documentation, CRFs, drug dispensing logs, and study related communication. Analyzes protocols and advises treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics. Supports quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups. Accountable for all tasks in basic clinical studies. Performs other related work as needed. Minimum Qualifications Education: Minimum requirements include a college or university degree in related field. Work Experience: Minimum requirements include knowledge and skills developed through < 2 years of work experience in a related job discipline. Certifications: --- Preferred Qualifications Education: Bachelor's degree in related field. Experience: 2+ years of experience in clinical research or adjacent field strongly preferred. Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines. Knowledge of medical terminology. Understanding of the IRB submission and review process and when and how to apply for IRB review. Understanding of the federal research regulations and the ability to identify the federal research organizations role in regulating human research participation. Preferred Competencies Interact and communicate with clarity, tact, and courtesy with patients, staff, faculty, students, and others. Strong organizational skills. Strong communication skills, verbal and written. Strong data management skills and attention to detail. Read and understand complex documents. Handle competing demands. Working Conditions Office Environment. 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. Job Family Research Role Impact Individual Contributor Scheduled Weekly Hours 40 Drug Test Required Yes Health Screen Required Yes Motor Vehicle Record Inquiry Required No Pay Rate Type Salary FLSA Status Exempt Pay Range $50,000.00 - $65,000.00 The included pay rate or range represents the Universitys good faith estimate of the possible compensation offer for this role at the time of posting. Benefits Eligible Yes The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook. Posting Statement The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination. Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via Applicant Inquiry Form. All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position. 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: http://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. 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 http://www.uchicago.edu/