University of Chicago
Lead Clinical Research Coordinator
University of Chicago, Chicago, Illinois, United States, 60290
Overview
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. Department
BSD NEU - Administration Job Summary
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. Education and Qualifications
Minimum Qualifications: a college or university degree in related field. Work Experience: 7+ years of work experience in a related job discipline. Certifications: (not specified in the description). Experience and Competencies
Clinical research experience coordinating multiple and varied studies (e.g., investigator initiated; industry sponsored; multi-site trials). Previous experience managing staff. Safety awareness and ability to follow instructions, communicate effectively, and manage complex information. Application Documents
Resume (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 Details
Job Family: Research Role Impact: Individual Contributor Scheduled Weekly Hours: 40 Drug Test Required: Yes Health Screen Required: Yes Motor Vehicle Record Inquiry Required: No Pay Rate Type: Salary FLSA Status: Exempt Pay Range: $80,000.00 - $100,000.00 The 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 and Equal Opportunity
Benefits Eligible: Yes. The 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 the Benefits Guidebook. Posting Statement: 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. For additional information please see the University’s Notice of Nondiscrimination. If a reasonable accommodation is needed to complete the application process, please contact the listed accommodations line. 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. The University considers conviction information on a case-by-case basis and assesses the nature of the offense, circumstances, timing, and relevance to the position. Notice
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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. Department
BSD NEU - Administration Job Summary
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. Education and Qualifications
Minimum Qualifications: a college or university degree in related field. Work Experience: 7+ years of work experience in a related job discipline. Certifications: (not specified in the description). Experience and Competencies
Clinical research experience coordinating multiple and varied studies (e.g., investigator initiated; industry sponsored; multi-site trials). Previous experience managing staff. Safety awareness and ability to follow instructions, communicate effectively, and manage complex information. Application Documents
Resume (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 Details
Job Family: Research Role Impact: Individual Contributor Scheduled Weekly Hours: 40 Drug Test Required: Yes Health Screen Required: Yes Motor Vehicle Record Inquiry Required: No Pay Rate Type: Salary FLSA Status: Exempt Pay Range: $80,000.00 - $100,000.00 The 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 and Equal Opportunity
Benefits Eligible: Yes. The 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 the Benefits Guidebook. Posting Statement: 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. For additional information please see the University’s Notice of Nondiscrimination. If a reasonable accommodation is needed to complete the application process, please contact the listed accommodations line. 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. The University considers conviction information on a case-by-case basis and assesses the nature of the offense, circumstances, timing, and relevance to the position. Notice
Referrals increase your chances of interviewing at University of Chicago. Get notified about new Clinical Research Coordinator jobs in Chicago, IL.
#J-18808-Ljbffr