Senior Clinical Research Associate - C

Title: Senior Clinical Research Associate - C

Location: Des Plaines, IL

Duration: 12 Month

Job Description:

The Senior Clinical Research Associate (CRA) supports the Companion Diagnostic (CDx) clinical team by managing and executing Phase I–IV clinical studies in compliance with Federal Regulations, ICH guidelines, and study protocols. This role is responsible for ensuring high-quality clinical trial execution, effective vendor and site management, and accurate clinical documentation throughout the study lifecycle.

Key Responsibilities:

• Manage and monitor Phase I–IV CDx clinical studies in accordance with regulatory requirements and study protocols
• Plan and support overall study conduct, including timelines, milestones, and deliverables
• Contribute to the development and review of clinical study protocols and related documents
• Design and review case report forms (CRFs)
• Support selection, training, and management of CROs and external vendors
• Assist with selection, training, and oversight of study investigators and clinical sites
• Plan, organize, and participate in investigator meetings and study-related meetings
• Support evaluation and onboarding of new study investigators
• Assist with study budget development and contract negotiations with CROs and study sites
• Contribute to the preparation, review, and supervision of clinical study reports and regulatory documents, including NDA components such as ISS and ISE, as applicable
• Ensure accurate documentation and compliance with internal procedures and regulatory standards
• Support cross-functional collaboration with internal stakeholders

Qualifications:

• Bachelor’s degree in life sciences or a related field
• Minimum of 5 years of clinical research experience, preferably in Companion Diagnostics
• Strong knowledge of ICH-GCP and applicable regulatory requirements
• Experience working with CROs and clinical investigators
• Basic proficiency in Microsoft Word, Excel, and PowerPoint
• Strong organizational, communication, and problem-solving skills
• Ability to travel internationally as required

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k) 

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs