University of Chicago
Clinical Research Coordinator 2
University of Chicago, Chicago, Illinois, United States, 60601
Clinical Research Coordinator 2
The Clinical Research Coordinator 2 (CRC2) is a specialized researcher partnering with the clinical Principal Investigator (PI) and under the direction of a departmental or lab research manager. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC2 supports, facilitates, and coordinates independently the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties with limited supervision and/or guidance, the CRC2 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 study. Responsibilities include: Managing all aspects of conducting clinical trials including screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports. Recruiting and interviewing potential study patients with guidance from PI and other clinical research staff. Collecting, processing, shipping, and storing specimens to the appropriate laboratory according to established aseptic techniques. Identifying and explaining the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations, and regulatory authorities related to the conduct of a clinical trial. Coordinating the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence. Planning and coordinating patient schedule for study procedures, return visits, and study treatment schedules. Educating patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures. Performing assessments at visits and monitoring for adverse events. Organizing and attending site visits from sponsors and other relevant study meetings. Protecting patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols. Ensuring Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications. Maintaining accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication. Understanding the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions independently. Ensuring compliance with federal regulations and institutional policies. May prepare and maintain protocol submissions and revisions. May assist in the training of new or backup coordinators. Facilitating and participating in the daily activities of moderately complex clinical studies and performing various activities including patient data retrieval, documenting clinical research records, and participation in program audits. Accountable for all tasks in moderately complex clinical studies. Performs other related work as needed. Minimum qualifications include a college or university degree in a related field and knowledge and skills developed through 2-5 years of work experience in a related job discipline. Preferred qualifications include a bachelor's degree, clinical research experience or relevant experience, experience coordinating multiple studies, and various competencies such as communication, technical document comprehension, and interpersonal relationship development. Application documents required include a resume and cover letter.
The Clinical Research Coordinator 2 (CRC2) is a specialized researcher partnering with the clinical Principal Investigator (PI) and under the direction of a departmental or lab research manager. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC2 supports, facilitates, and coordinates independently the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties with limited supervision and/or guidance, the CRC2 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 study. Responsibilities include: Managing all aspects of conducting clinical trials including screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports. Recruiting and interviewing potential study patients with guidance from PI and other clinical research staff. Collecting, processing, shipping, and storing specimens to the appropriate laboratory according to established aseptic techniques. Identifying and explaining the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations, and regulatory authorities related to the conduct of a clinical trial. Coordinating the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence. Planning and coordinating patient schedule for study procedures, return visits, and study treatment schedules. Educating patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures. Performing assessments at visits and monitoring for adverse events. Organizing and attending site visits from sponsors and other relevant study meetings. Protecting patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols. Ensuring Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications. Maintaining accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication. Understanding the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions independently. Ensuring compliance with federal regulations and institutional policies. May prepare and maintain protocol submissions and revisions. May assist in the training of new or backup coordinators. Facilitating and participating in the daily activities of moderately complex clinical studies and performing various activities including patient data retrieval, documenting clinical research records, and participation in program audits. Accountable for all tasks in moderately complex clinical studies. Performs other related work as needed. Minimum qualifications include a college or university degree in a related field and knowledge and skills developed through 2-5 years of work experience in a related job discipline. Preferred qualifications include a bachelor's degree, clinical research experience or relevant experience, experience coordinating multiple studies, and various competencies such as communication, technical document comprehension, and interpersonal relationship development. Application documents required include a resume and cover letter.