Clinical Research Coordinator 2

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. The CRC2 recruits and interviews potential study patients with guidance from PI and other clinical research staff. They collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques. The CRC2 identifies and explains the responsibilities of principal investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial. They coordinate 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. The CRC2 plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules. They educate patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures. The CRC2 performs assessments at visits and monitors for adverse events. They organize and attend site visits from sponsors and other relevant study meetings. The CRC2 protects patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols. They ensure Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications. The CRC2 maintains 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. They understand 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. The CRC2 ensures compliance with federal regulations and institutional policies. They may prepare and maintain protocol submissions and revisions. They may assist in the training of new or backup coordinators. The CRC2 assists with various professional, organizational, and operational tasks under moderate supervision. They facilitate and participate in the daily activities of moderately complex clinical studies and perform various activities including patient data retrieval, documenting clinical research records, and participation in program audits. The CRC2 uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a limited to moderate degree of independence. They contribute to the problem solving on assigned clinical research studies and tasks. The CRC2 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 in a related field and relevant clinical research experience. Preferred competencies include the ability to communicate clearly, professionally, and effectively with patients, faculty, staff, research teams, sponsors, and other stakeholders. The CRC2 should have strong organizational and time management skills with the ability to manage multiple clinical research activities, prioritize competing demands, and meet established deadlines. They should be able to establish and maintain effective working relationships with diverse individuals and collaborate across multidisciplinary teams. The CRC2 should have strong data management skills with demonstrated attention to detail, accuracy, and completeness in maintaining research records and documentation. They should be proficient in Microsoft Office applications, including Outlook, Word, and Excel, and the ability to learn and utilize clinical research databases and electronic systems. The CRC2 should be able to interpret and apply complex clinical research protocols, regulatory requirements, and study documentation while identifying and resolving issues appropriately. They should be able to exercise sound judgment, take ownership of assigned responsibilities, and complete work accurately and timely with limited supervision. The CRC2 should be able to adapt to changing research priorities, study requirements, and work assignments while maintaining productivity and quality. They should be able to quickly comprehend, retain, and apply new information, including complex study protocols, procedures, and regulatory requirements. The CRC2 should be able to understand and adhere to clinical research regulations, institutional policies, study protocols, and confidentiality requirements to support research integrity and participant safety.

Working conditions include the ability to navigate assigned University of Chicago locations, including clinical, research, and administrative areas, as required by the position. Work is performed in clinical research, patient care, and office environments, with potential exposure to biological specimens and other clinical research materials. The CRC2 should be able to adhere to established safety protocols and infection prevention procedures, including the use of personal protective equipment as required. They may require flexibility in work schedules to accommodate clinical research activities, patient visits, and study requirements. Hybrid work arrangements may be considered based on operational needs and position responsibilities.

Application documents include a resume (required) and a cover letter (preferred). The University of Chicago uses AI-assisted tools to streamline and augment some recruitment processes; however, AI is not used to make hiring decisions. When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.