University of Chicago Senior Clinical Research Coordinator in chicago, Illinois

This job was posted by : For more information, please see: Company Job ID-JR03448Job 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). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of clinical trials, 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. The Sr CRC acts as a leader within the department/unit through improving clinical research practice and serves as a resource to others. By performing these duties, the Sr. CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical studies.Responsibilities:Research Conduct/Study Management:Assist with or plan and implement the clinical study's goals and objectives; organize patient enrollment planning; conduct quality assurance activities, compile and analyze data.Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities.Serve as a resource person or act as a consultant within area of clinical expertise.Act as a leader within the department/unit through improving clinical research practice and serving as a resource.Maintain working knowledge of current protocols, and internal SOPs.Be accountable for high standards of clinical research practice and assist in the development of accountability in others.Data Management:Develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected.Regulatory:Oversee and participate in the coordination and conduct of complex clinical research studies and ensure compliance with federal and institutional regulations.Prepare, submit, and assist Investigators with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).Provide Investigators with guidance regarding protocol requirements.Maintain regulatory documentation.Assist other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee.Prepare for and assist with audits, inspections, and monitoring visits from regulatory agencies or sponsors.Supervision:Provide direct supervision of other CRC staff (i.e. hiring/firing, performance evaluations, disciplinary actions, approve time off, etc.), or assist.Other Duties:Attend continuing education and training opportunities relevant to job duties.Other duties as assigned. Competencies:Ability to train junior CRCs required.Ability to participate in protocol review and clinical trials evaluations required.Excellent interpersonal skills required.Strong data management skills and attention to detail required.Ability to handle competing demands with diplomacy and enthusiasm required.Ability to work collaboratively with faculty and divisional clinical research infrastructure required.Excellent time management and ability to prioritize work assignments required.Ability to read and understand clinical trials protocols required.Familiarity with medical terminology/environment required.Working knowledge of Good Clinical Practices (GCP) required.Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat required.Research certification (e.g., SoCRA, ACRP, Graham School Clinical Trials Management & Regulatory Compliance) preferred. Additional Information: Education and Experience:Bachelor's degree required.Minimum of 5 years of clinical research experience co ordinating multiple and variety of studies (e.g., investigator initiated; industry sponsored; multi-site trials) required. See job URL for more information and EOE statement.The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, status as an individual with a disability, protected veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.