Onsite Neurology Clinical Research Coordinator II

Biological Sciences Division at the University of Chicago; Chicago (IL); On-site; USD 60,000 - 75,000; Full time

Job summary

The Biological Sciences Division at the University of Chicago seeks a Clinical Research Coordinator II to support daily trial activities onsite, partnering with the PI and the Clinical Research Manager. The CRC II coordinates screening, enrollment, consent, data collection, and adverse event reporting in line with protocol and regulatory requirements.

Key duties include IRB submissions, study coordination from startup to closeout, data integrity, SOP adherence, and training of new coordinators.

Qualifications

• Minimum requirements include a college or university degree in related field.
• Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.
• Clinical research experience or relevant experience preferred.
• Experience coordinating multiple studies (e.g., investigator initiated, industry sponsored, multi-site trials).

Responsibilities

• Manages all aspects of conducting clinical trials including screening, enrollment, subject follow-up, completion of case report forms, and adverse event reports.
• Coordinates 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 and data integrity.
• Recruits and interviews potential study patients with guidance from PI and other clinical research staff.
• Obtains informed consent.
• Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.
• Performs assessments at visits and monitors for adverse events.
• Organizes and attends site visits from sponsors and other relevant study meetings.
• Protects patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.
• Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.
• 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.
• Understands 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.
• Ensures 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.
• Accountable for all tasks in moderately complex clinical studies.
• Assists with various professional, organizational, and operational tasks under moderate supervision.
• Performs other related work as needed.

Skills

Communication skills

Interpersonal skills

Adaptability

Technical document comprehension

Relationship management

Discretion/Confidentiality

Following instructions

Multitasking

Time management

Training others

GCP knowledge

Education

Bachelor's degree

Job description

The Biological Sciences Division at the University of Chicago seeks a Clinical Research Coordinator II to support daily trial activities onsite, partnering with the PI and the Clinical Research Manager. The CRC II coordinates screening, enrollment, consent, data collection, and adverse event reporting in line with protocol and regulatory requirements.

Key duties include IRB submissions, study coordination from startup to closeout, data integrity, SOP adherence, and training of new coordinators.