Clinical Research Coordinator 1, Islet Lab

DepartmentBSD SUR - Transplant Surgery: Research - Islet LabAbout the DepartmentThe Section of Transplantation is built on a strong history of surgical excellence, including the first-ever animal organ transplant in 1904. Over the years, the section has gone on to achieve many more 'firsts,' including the first successful living donor liver transplant and the first heart-liver-kidney transplant in the world. Today, UChicago Medicine is home to one of the busiest organ transplant centers in the nation and offers more transplant options than any other program in Illinois. What our surgeons can achieve in the operating room would not be possible without the ongoing work that is done in our laboratories, and this is especially true in the Section of Transplantation. Our researchers are well known for their basic science research in transplantation tolerance and clinical trial work around islet cell transplantation for diabetes.Job SummaryThis 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 within the Islet Lab.ResponsibilitiesManages all aspects of conducting clinical trials and clinical research studies from startup to closeout for one or two 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 schedule 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.Reviews the protocol plan to understand and assist with planning for the various costs and resources required such as clinical care expenses, personnel effort, site initiation costs (IRB fees, pharmacy costs, etc.), equipment, and supplies.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.Accountable for all tasks in basic clinical studies.Assists with various professional, organizational, and operational tasks under direct supervision.Supports quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples.Performs other related work as needed.Minimum QualificationsEducation: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 QualificationsEducation:Bachelor's degree in a related field.Technical Skills or Knowledge: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 CompetenciesInteract 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.Application DocumentsResume/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.Job FamilyResearchRole ImpactIndividual ContributorScheduled Weekly Hours40Drug Test RequiredYesHealth Screen RequiredYesMotor Vehicle Record Inquiry RequiredNoPay Rate TypeSalaryFLSA StatusExemptPay Range$50, $65,000.00The included pay rate or range represents the University's good faith estimate of the possible compensation offer for this role at the time of posting.Benefits EligibleYesThe 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 theBenefits Guidebook.Posting StatementThe 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 theUniversity's Notice of Nondiscrimination.Job seekers in need of a reasonable accommodation to complete the application process should call or submit a request viaApplicant 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:. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.