Clinical Research Associate II - Chicago, Midwest

About the role

A Clinical Research Associate II (CRA II) specializing in oncology, you will play a crucial role in the execution and management of Phase 1, Phase 2, and Phase 3 clinical trials. You will collaborate closely with cross-functional teams to ensure adherence to protocols, regulatory requirements, and high-quality standards throughout the clinical trial process.

Responsibilities

• Study Initiation and Planning: Participate in study feasibility assessments, and site selection processes
• Assist in the preparation and review of essential documents such as informed consent forms (ICFs) and study manuals
• Clinical Trial Monitoring: Conduct site qualification, site initiation, interim monitoring, and close-out visits to ensure compliance with the study protocol, Good Clinical Practice (GCP), and regulatory guidelines
• Regularly review Investigator Site Files (ISF) to assist in maintaining site audit readiness
• Perform routine site communication, including resolving site issues and providing protocol training as necessary
• Leadership: Contribute to development and delivery of CRA training materials
• Mentor and support junior CRAs and newly onboarded CRAs
• Review study documents including the Clinical Monitoring Plan and Investigator Site File documents
• Participate in trial risk management meetings and procedures
• Identify, develop and implement process improvement initiatives to enhance monitoring quality and mitigate trial risks
• Data Collection and Management: Monitor and review clinical data to ensure accuracy, completeness, and timeliness
• Work closely with data management teams to resolve data discrepancies and ensure data integrity throughout the trial
• Regulatory Compliance: Assist in the preparation of regulatory submissions and support inspections/audits as needed
• Collaboration and Communication: Foster strong relationships with investigators, study coordinators, and other key stakeholders
• Provide regular updates to internal teams and management regarding study progress, issues, and resolutions

Qualifications

• Education/Experience: Bachelor’s degree in life sciences or a related field; minimum 2 years oncology experience (or commensurate)
• Knowledge / Skill / Ability: Proficiency in understanding clinical trial protocols, GCP, regulatory requirements, EDC, EMR, eTMF, and CTMS; strong organizational skills with attention to detail and the ability to prioritize tasks effectively; ability to effectively and efficiently perform source data verification (SDV); ability to identify protocol deviations and effectively identify root cause and assist sites in implementing corrective or preventative actions; excellent communication and interpersonal skills, both written and verbal; ability to travel domestically and internationally as required; ability to perform the CRA role without significant onboarding or training; can manage complex protocols/sites; grows to lead other CRAs

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.