University of Chicago
Lead Clinical Research Coordinator
University of Chicago, Chicago, Illinois, United States, 60290
Lead Clinical Research Coordinator
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. The Lead Clinical Research Coordinator is a specialized research professional working with and under the direction of clinical Principal Investigators (PIs). The position oversees, facilitates and coordinates the daily activities of complex clinical research studies, which may include the oversight of a multi-site clinical research grant, and plays a critical role in the conduct of the studies to ensure compliance with federal and institutional regulations. This position may contribute to the publications and research related to the trial and work with PIs on the input of new trial and grant submissions. This role acts as a leader within the department/unit through improving clinical research practice and serves as a resource to others. 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. Oversee aspects of financial management related to applicable studies and grants and will partner with department leaders to identify new research opportunities and strategic priorities in their related field of research. The incumbent will be responsible for overseeing adherence to department and University research standard operating procedures within their team, as well as introducing new processes to positively impact efficiency and success in trial selection, start up and ongoing performance within their team. Independently manages the collection, documentation, analysis of complex clinical studies, and reporting of clinical research data. Responsibilities Provides input into the strategic, administrative, and operational decisions that impact clinical research conducted across the University. 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 area of clinical expertise. Supervises junior staff. Oversees financial performance of their and their team's trial portfolio. Conducts regulatory work in accordance with requirements for their or their team's studies. 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 conduct 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. Attends continuing education and training opportunities relevant to job duties. Accountable for all tasks in highly complex clinical studies. Oversees and participates in the daily activities of highly complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits. Uses expert knowledge of clinical research to coordinate the collection of analyzable data and/or samples with the highest degree of independence. 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 Experience: Clinical research experience coordinating multiple and variety of studies (e.g., investigator initiated; industry sponsored; multi-site trials). Previous experience managing staff. Preferred Competencies Aware of safety hazards and take appropriate precautions. Communicate in writing. Communicate orally. Comprehend technical documents. Condense complicated issues to simple summaries that can be understood by a variety of constituents. Create and deliver presentations. Develop and manage interpersonal relationships. Exercise absolute discretion regarding confidential matters. Follow written and/or verbal instructions. Give directions. Handle sensitive matters with tact and discretion. Handle stressful situations. Learn and develop skills. Maintain a high level of alertness. Pay attention to detail. Perform multiple tasks simultaneously. Prioritize work and meet deadlines. React effectively, quickly, calmly, and rationally during conflicts and emergencies. Train or teach others. Work effectively and collegially with little supervision or as member of a team. Work independently. Application Documents Resume (required) Cover Letter (required)
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. The Lead Clinical Research Coordinator is a specialized research professional working with and under the direction of clinical Principal Investigators (PIs). The position oversees, facilitates and coordinates the daily activities of complex clinical research studies, which may include the oversight of a multi-site clinical research grant, and plays a critical role in the conduct of the studies to ensure compliance with federal and institutional regulations. This position may contribute to the publications and research related to the trial and work with PIs on the input of new trial and grant submissions. This role acts as a leader within the department/unit through improving clinical research practice and serves as a resource to others. 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. Oversee aspects of financial management related to applicable studies and grants and will partner with department leaders to identify new research opportunities and strategic priorities in their related field of research. The incumbent will be responsible for overseeing adherence to department and University research standard operating procedures within their team, as well as introducing new processes to positively impact efficiency and success in trial selection, start up and ongoing performance within their team. Independently manages the collection, documentation, analysis of complex clinical studies, and reporting of clinical research data. Responsibilities Provides input into the strategic, administrative, and operational decisions that impact clinical research conducted across the University. 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 area of clinical expertise. Supervises junior staff. Oversees financial performance of their and their team's trial portfolio. Conducts regulatory work in accordance with requirements for their or their team's studies. 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 conduct 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. Attends continuing education and training opportunities relevant to job duties. Accountable for all tasks in highly complex clinical studies. Oversees and participates in the daily activities of highly complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits. Uses expert knowledge of clinical research to coordinate the collection of analyzable data and/or samples with the highest degree of independence. 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 Experience: Clinical research experience coordinating multiple and variety of studies (e.g., investigator initiated; industry sponsored; multi-site trials). Previous experience managing staff. Preferred Competencies Aware of safety hazards and take appropriate precautions. Communicate in writing. Communicate orally. Comprehend technical documents. Condense complicated issues to simple summaries that can be understood by a variety of constituents. Create and deliver presentations. Develop and manage interpersonal relationships. Exercise absolute discretion regarding confidential matters. Follow written and/or verbal instructions. Give directions. Handle sensitive matters with tact and discretion. Handle stressful situations. Learn and develop skills. Maintain a high level of alertness. Pay attention to detail. Perform multiple tasks simultaneously. Prioritize work and meet deadlines. React effectively, quickly, calmly, and rationally during conflicts and emergencies. Train or teach others. Work effectively and collegially with little supervision or as member of a team. Work independently. Application Documents Resume (required) Cover Letter (required)