Sr. Clinical Research Coordinator

About the role

The Senior Clinical Research Coordinator (Sr CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). This position oversees, facilitates, and coordinates the daily activities of complex clinical trials and plays a critical role in their conduct to ensure compliance with federal and institutional regulations.

This position independently manages the collection, documentation, analysis, and reporting of clinical trial data. It also serves as a leader within the department/unit by improving clinical research practices and 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

• 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.
• 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 conducts quality assurance of collected data.
• 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.
• Affords assistance to regulatory agencies, such as the IRB, FDA, and Data and Safety Review Committee.
• Attends continuing education and training opportunities relevant to job duties.
• Accounts for all tasks in complex clinical studies.
• Facilitates and participates in the daily activities of complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.
• Uses in-depth knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a high degree of independence.

Requirements

Education: Minimum requirements include a college or university degree in related field.

Work Experience: Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline.

Qualifications

Education: Bachelor's Degree in a related field.

Experience: Familiarity with Clinical trials terminology, environment, and protocols. Work experience in a related job discipline with 5-7 years of experience.

Skills

Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.

Strong organizational skills.

Excellent interpersonal skills.

Strong data management skills and attention to detail.

Knowledge of the Microsoft Suite, including Outlook.

Ability to understand complex documents (e.g., clinical trials).

Ability to handle competing demands with diplomacy and enthusiasm.

Ability to absorb large amounts of information quickly.

Adaptability to changing working situations and work assignments.

Benefits

The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off.