University of Chicago
Senior Clinical Research Coordinator
University of Chicago, Chicago, Illinois, United States, 60290
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Senior Clinical Research Coordinator
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University of Chicago The University of Chicago Comprehensive Cancer Center (UCCCC) is an integral component of the Biological Sciences Division (BSD). The BSD is the largest of four Divisions of the University and includes the Pritzker School of Medicine. Job Summary The Senior Clinical Research Coordinator (Sr CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). The Sr CRC oversees, facilitates, and coordinates the daily activities of complex clinical trials and plays a critical role in the conduct of the studies to ensure compliance with federal and institutional regulations. Responsibilities Acts as a leader within the department/unit through improving clinical research practice; serves as a resource person or a consultant within the 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. Provides investigators with guidance regarding protocol requirements. Maintains regulatory documentation. Assists other research personnel with reports to regulatory agencies like 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. Facilitates and participates in the daily activities of complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits. Performs other related work as needed. Education: 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 Qualifications include research certification, such as SoCRA, ACRP, and Graham School Clinical Trials Management and Regulatory Compliance. Technical Skills Or Knowledge: Participate in protocol review and clinical trial evaluations. Read and understand clinical trial protocols. Familiarity with medical terminology/environment. Working knowledge of Good Clinical Practices (GCP). Extensive knowledge of Microsoft Word, Excel, and Adobe Acrobat. Preferred Competencies Train junior CRCs. Excellent 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 ability to prioritize work assignments. 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.
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Senior Clinical Research Coordinator
role at
University of Chicago The University of Chicago Comprehensive Cancer Center (UCCCC) is an integral component of the Biological Sciences Division (BSD). The BSD is the largest of four Divisions of the University and includes the Pritzker School of Medicine. Job Summary The Senior Clinical Research Coordinator (Sr CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). The Sr CRC oversees, facilitates, and coordinates the daily activities of complex clinical trials and plays a critical role in the conduct of the studies to ensure compliance with federal and institutional regulations. Responsibilities Acts as a leader within the department/unit through improving clinical research practice; serves as a resource person or a consultant within the 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. Provides investigators with guidance regarding protocol requirements. Maintains regulatory documentation. Assists other research personnel with reports to regulatory agencies like 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. Facilitates and participates in the daily activities of complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits. Performs other related work as needed. Education: 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 Qualifications include research certification, such as SoCRA, ACRP, and Graham School Clinical Trials Management and Regulatory Compliance. Technical Skills Or Knowledge: Participate in protocol review and clinical trial evaluations. Read and understand clinical trial protocols. Familiarity with medical terminology/environment. Working knowledge of Good Clinical Practices (GCP). Extensive knowledge of Microsoft Word, Excel, and Adobe Acrobat. Preferred Competencies Train junior CRCs. Excellent 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 ability to prioritize work assignments. 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.
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