Clinical Research Manager

Department BSD NEU - Administration About the Department The Department of Neurology at The University of Chicago Medical Center has a great history and tradition, having made significant contributions to neurological training, clinical care, and the basic understanding of neurological disease. Job Summary The job manages a team of professional staff responsible for performing clinical research including the collection, documentation, analysis of clinical trial data, and reporting of clinical research data. Manages the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University. Responsibilities The Clinical Research Manager will provide project management, data management and clinical monitoring support for multiple types of trials (sponsored, grant funded, multi-site, and/or investigator-initiated trials) in the Department of Neurology. The Clinical Research Manager will act as a liaison between clinical sites, the Clinical Trials Office and sponsors/agencies to ensure that clinical trials are conducted in compliance with the protocol and applicable institutional and regulatory guidelines. Responsible for research project oversight and day-to-day supervision of Clinical Research Coordinators and other research staff employees as appropriate. Establishes, monitors, and controls project budgets, ensuring financial performance is robust. Conducts research in area of expertise. Collaborates with PIs and other researchers on long-range plans for research projects. Oversees the development of research projects and ensures progress according to plan. Investigates, modifies and applies new procedures, techniques or applications of technology. Establishes goals and operating procedures, practices, and guidelines. In collaboration with senior research faculty and personnel, participates as skilled individual contributor and/or lead researcher as expert in specialized area. Prepares grant/funding applications, manages financial, personnel, planning, compliance and other administrative aspects of research project(s). Oversees activities related to data collection and analysis. Coordinates the conduct of the study from screening through to completion including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence. Protects patients and data confidentiality by ensuring security of research data and personal health information. Ensures compliance of research activities with institutional, state, and federal regulatory policies, procedures, directives and mandates. Understands the federal research regulations and identifies the federal research organizations role in regulating human research participation. Identifies and explains the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial. Plans and manages the protocol review process for all clinical trials which includes the receipt and coordination of protocols for review, committee meetings, and clinical research conferences. Advises the development of a formalized training program for both new and existing staff within the unit and any affiliates and/or partners. Monitors federal regulatory agency requirements related to clinical research training requirements and ensures training activities comply with requirements. 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 7+ years of work experience in a related job discipline. Certifications: --- Preferred Qualifications Education: Master's degree in related field. Experience: Experience monitoring and auditing clinical research trials for compliance/billing accuracy (e.g., site monitoring, quality assurance, create monitoring plans). Experience managing research teams and projects. Experience in a leadership role. Preferred Competencies Ability to develop and manage clinical trials teams. Excellent time management skills and ability to work independently. Ability to develop and develop research programs and work strategically with Principal Investigators. Ability to lead robust operational and financial analysis of study(ies) and/or program performance. Ability to understand clinical trials protocols. Knowledge of regulatory policies and procedures. Strong analytical skills. Knowledge of grant and contract administration. Familiarity with medical and scientific terminology. Demonstrated knowledge of Good Clinical Practices (GCP). Ability to identify funding sources. Application Documents Resume/CV (required) Cover Letter (preferred) 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 People Manager 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 $90,000.00 - $130,000.00 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/