Clinical Research Associate (CRA)

Job Title: Clinical Research Associate (CRA)

Location: Lake Forest, IL (Onsite)

Duration: 12 Months

Job Summary:

We are seeking an experienced Clinical Research Associate (CRA) to support IVD and specimen collection studies. The role involves site monitoring, study coordination, and regulatory support while ensuring compliance with ICH GCP, FDA, and IRB guidelines .

Key Responsibilities:

• Support study planning, execution, and coordination
• Perform site selection, initiation, monitoring, and close-out activities
• Manage investigator sites and act as primary point of contact
• Ensure protocol adherence and timely patient enrollment
• Prepare and review regulatory documents, study protocols, and reports
• Review medical records and source documentation
• Manage CRF collection, data review, and cleanup
• Participate in study meetings and contribute to study summaries
• Mentor junior CRAs and support lead CRA activities

Required Skills & Experience:

• 5+ years of clinical research monitoring experience
• Strong knowledge of ICH GCP, FDA, and IRB regulations
• Hands-on experience in site monitoring and management
• Experience with source data verification and medical record review
• Strong communication and stakeholder management skills
• Leadership or mentoring experience