Clinical Research Associate II

Icon - Chicago, IL

Full-time - Mid Level

Chicago, IL

Professional, Scientific, and Technical Services

About the position

As a Clinical Research Associate II (CRA II) at ICON, you will play a crucial role in the clinical research process, ensuring compliance with ICH-GCP guidelines and applicable regulations. You will be responsible for monitoring clinical trials both onsite and remotely, managing investigative site staff, and ensuring the integrity of clinical data. This position requires strong communication and organizational skills, as well as the ability to work independently and collaboratively with various stakeholders in the clinical research environment.

Responsibilities

• Completes onsite and remote monitoring activities in accordance with ICH-GCP guidelines, applicable regulations, SOPs, and study processes.
• Qualifies potential investigative sites and initiates clinical trials.
• Maintains study files and provides instructions to site personnel during study close out.
• Verifies the protection of study participants by confirming informed consent procedures and protocol compliance.
• Ensures the integrity of clinical data and compliance with the approved protocol, GCP, applicable regulations, and SOPs.
• Manages investigative site staff to facilitate trial deliverables, including subject enrollment and data deliverables.
• Writes and submits reports of investigational site findings and updates applicable tracking systems.
• Escalates observed deficiencies, issues, and corrective and preventative action plans as appropriate.
• Manages essential documents as required by local regulations and ICH-GCP guidelines before, during, and after a clinical study.
• Performs key risk assessment and management responsibilities throughout the project, including site health analysis and project escalation.
• Participates in audit preparation and follow-up activities as needed.
• Independently performs a variety of onsite and offsite monitoring visit types.
• Gathers and reviews information for assigned sites and identifies inconsistencies.
• Assists with non-complex ad hoc, short-term assignments in support of additional studies or departmental initiatives.
• May serve as preceptor, providing training to less experienced clinical team members.

Requirements

• 2 years of experience supporting clinical trials including 2 years of on-site monitoring experience.
• In-depth knowledge of the drug development process.
• In-depth knowledge and practical utilization of ICH-GCP and applicable regulatory requirements.
• Sound knowledge of applicable policies and procedures, SOPs, work instructions, and other guidance documents.
• Good spoken and written communication skills; good presentation skills.
• Strong interpersonal, collaboration, and time management skills.
• High proficiency with Microsoft Office and company collaboration applications.
• Excellent skill in the utilization of applicable clinical systems.
• Excellent critical thinking skills.
• Excellent organizational skills.
• Ability to focus on detail for extended periods of time; high attention to accuracy.
• Ability to travel extensively.
• Ability to establish and maintain effective working relationships with investigative site staff.
• Undergraduate degree or international equivalent in clinical, science, or health-related field from an accredited institution; health care professional licensure, i.e., registered nurse.

Nice-to-haves

• Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above.

Benefits

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family's needs
• Competitive retirement planning offerings
• Global Employee Assistance Programme, offering 24-hour access to a global network of professionals
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments