University of Chicago (UC)
Senior Clinical Research Coordinator
University of Chicago (UC), Chicago, Illinois, United States, 60290
Location: AdventHealth Hinsdale
Job Description: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.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.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 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.Provides direct supervision of other CRC staff, including but not limited to, hiring/firing, performance evaluations, disciplinary actions, manage time off, etc.Attends continuing education and training opportunities relevant to job duties.Solves complex problems relating to data management and the analysis of large administrative datasets. Works independently to develop, manage, and report on key data and ensures timeliness of data and reporting submissions from multiple investigators.Acts as a resource on the basics of clinical research and related aspects of clinical study for colleagues with less experience. Prepares and evaluates writing protocols, IRB submissions, grant applications, manuscripts, reports, and dissemination tools.Performs other related work as needed.Preferred QualificationsEducation:Bachelor’s degree.Experience:Minimum of 5 years of clinical research experience coordinating multiple and variety of studies, e.g., investigator initiated; industry sponsored; multi-site trials.Licenses and Certifications:Research certification, e.g., SoCRA, ACRP, Graham School Clinical Trials Management and Regulatory Compliance.Technical Skills or Knowledge:Train junior CRCs.Participate in protocol review and clinical trials evaluations.Read and understand clinical trials protocols.Familiarity with medical terminology/environment.Working knowledge of Good Clinical Practices (GCP).Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat.Preferred CompetenciesExcellent interpersonal skills.Strong data management skills and attention to detail.Handle competing demands with diplomacy and enthusiasm.Work collaboratively with faculty and divisional clinical research infrastructure.Excellent time management and prioritize work assignments.Working ConditionsBend, crouch, or stoop.Lift loads up to 49 lbs.Hybrid position with majority of work being done in-person/on-site.Application DocumentsResume/CV (required)
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Job Description: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.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.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 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.Provides direct supervision of other CRC staff, including but not limited to, hiring/firing, performance evaluations, disciplinary actions, manage time off, etc.Attends continuing education and training opportunities relevant to job duties.Solves complex problems relating to data management and the analysis of large administrative datasets. Works independently to develop, manage, and report on key data and ensures timeliness of data and reporting submissions from multiple investigators.Acts as a resource on the basics of clinical research and related aspects of clinical study for colleagues with less experience. Prepares and evaluates writing protocols, IRB submissions, grant applications, manuscripts, reports, and dissemination tools.Performs other related work as needed.Preferred QualificationsEducation:Bachelor’s degree.Experience:Minimum of 5 years of clinical research experience coordinating multiple and variety of studies, e.g., investigator initiated; industry sponsored; multi-site trials.Licenses and Certifications:Research certification, e.g., SoCRA, ACRP, Graham School Clinical Trials Management and Regulatory Compliance.Technical Skills or Knowledge:Train junior CRCs.Participate in protocol review and clinical trials evaluations.Read and understand clinical trials protocols.Familiarity with medical terminology/environment.Working knowledge of Good Clinical Practices (GCP).Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat.Preferred CompetenciesExcellent interpersonal skills.Strong data management skills and attention to detail.Handle competing demands with diplomacy and enthusiasm.Work collaboratively with faculty and divisional clinical research infrastructure.Excellent time management and prioritize work assignments.Working ConditionsBend, crouch, or stoop.Lift loads up to 49 lbs.Hybrid position with majority of work being done in-person/on-site.Application DocumentsResume/CV (required)
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