Sr. Clinical Research Coordinator

University of Chicago•Orland Park, IL

1d•Hybrid

About The Position

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 their conduct to ensure compliance with federal and institutional regulations. The Sr CRC 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. This position independently manages the collection, documentation, analysis, and reporting of clinical trial data. Provides input into the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University.

Requirements

Minimum requirements include a college or university degree in related field.
Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline.

Nice To Haves

Bachelor's Degree in a related field.
Familiarity with Clinical trials terminology, environment, and protocols.
Working knowledge of Good Clinical Practices (GCP).
Minimum of 5 years of experience participating in protocol reviews and clinical trial evaluations.
Research certification, e.g., SoCRA, ACRP, Graham School Clinical Trials Management and Regulatory Compliance.
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.

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.
Acts as a leader within the department/unit through improving clinical research practice; serves as a resource person or acts as a consultant within the area of clinical expertise.
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.
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 complex clinical studies.
Performs various professional, organizational, and operational tasks under limited supervision.
Acts as a resource on clinical research and related aspects of clinical study for other clinical research staff.
Accountable for complex problem solving on assigned clinical research studies and professional tasks.
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.
Performs other related work as needed.