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Senior Clinical Research Coordinator
6 days ago
DepartmentBSD NEU - Clinical Research StaffAbout the DepartmentThe 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 SummaryThe Senior Clinical Research Coordinator is an onsite, patient-facing, specialized researcher partnering with the clinical Principal Investigators (PI) and under the direction of the Clinical Research Manager. The position oversees, facilitates and coordinates the daily activities of complex clinical research studies and plays a critical role in the conduct of the studies to ensure compliance with federal and institutional regulations. They will directly manage a subset of clinical research staff members and provide guidance and mentorship to junior team members, including support with trial start up and regulatory needs.
ResponsibilitiesManages all aspects of conducting clinical trials including screening, enrollment, subject follow-up, completion of case report forms, and adverse event reports. Provides input into the strategic, administrative, and operational decisions that impact clinical research conducted within the department. 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 an area of clinical expertise. Supervises junior staff. May assist in the training of new or backup coordinators.
Conducts regulatory work in accordance with requirements for their own studies or those of their team. 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 conducts quality assurance on data collected.
Oversees and participates in the coordination and conduct of moderately 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 complex clinical studies. Performs various professional, organizational, and operational tasks under limited supervision. Acts as a resource on clinical research and related aspects of clinical study for other clinical research staff. Accountable for complex problem solving on assigned clinical research studies and professional tasks.
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 5-7 years of work experience in a related job discipline. Certifications:---Preferred QualificationsEducation:Advanced degree in related field.
Experience
Clinical research experience or relevant experience.
Experience
coordinating multiple studies (e.g., investigator initiated, industry sponsored, multi-site trials). Preferred CompetenciesStrong communication skills (verbal and written). Excellent interpersonal skills. Adaptability to changing working situations and work assignments.
Ability to comprehend technical documents. Ability to develop and manage interpersonal relationships. Ability to exercise absolute discretion regarding confidential matters. Ability to follow written and/or verbal instructions.
Ability to handle sensitive matters with tact and discretion. Ability to pay attention to detail. Ability to perform multiple tasks simultaneously. Excellent time management and ability to prioritize work assignments.
Ability to train or teach others. Working knowledge of Good Clinical Practice (GCP). Application DocumentsResume/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 FamilyResearchRole ImpactIndividual ContributorScheduled Weekly Hours40Drug Test RequiredYesHealth Screen RequiredYesMotor Vehicle Record Inquiry RequiredNoPay Rate TypeSalaryFLSA StatusExemptPay Range$70,000.00 - $85,000.00The 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 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.
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