Senior Clinical Research Associate

Senior Clinical Research Associate - Oncology Phase I - Chicago ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. The Sr. Clinical Research Associate (Sr. CRA) will be responsible for performing investigative site management and monitoring activities throughout the clinical trial lifecycle. This Sr. CRA role will support the client's Oncology clinical trials to ensure data integrity, subject safety, and inspection readiness at the clinical investigative sites. Responsibilities: Perform site management activities to support the client's Oncology site success and maintain a continuous state of inspection readiness Act as the primary contact and facilitate efficient communications between the client's clinical trial team and the sites Perform remote and on-site monitoring/co-monitoring visits (Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Close-Out Visits) to ensure data integrity and subject safety in the client's trials May perform oversight activities to assess monitoring quality and train/mentor less experienced CRAs Promptly document monitoring activities and submit/approve visit reports Manage site essential document collection and TMF reconciliation with site files Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirm approvals Regularly review site Key Risk Indicator (KRI) metrics, issues and action items to detect trends and ensure prompt resolution Independently determine root causes and develop/implement site Corrective Action and Preventive Action (CAPA) plans Deliver training to ensure sites comply with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and regulations Support sites and the client's regulatory inspections Contribute to site identification; drive site feasibility and qualification progress; and support site activation activities Lead site engagement initiatives and foster relationships with key Oncology sites and networks Qualifications Bachelors degree (scientific field preferred) 5+ years monitoring clinical trials independently conducting on-site and remote monitoring visits. Atleast 2 years monitoring solid tumor clinical trials. 1+ years early development trial experience Solid tumor clinical trial experience is required Experience utilizing Veeva systems is highly preferred Demonstrated experience developing/maintaining site relationships and securing compliance Expertise in GxPs and Oncology monitoring techniques (including Risk-Based Monitoring) and terminology Experience collaborating with sites from initial engagement through close-out phases Experience activating sites Experience training site staff Experience supporting sites and/or sponsors in regulatory inspections Experience working within a Functional Services (or in-house) monitoring model is preferred Willing to travel up to 50% Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: Competitive base salary and performance related incentives Health and wellbeing programmes including medical, dental, and vision coverage where applicable Retirement and pension plans Life assurance and disability coverage Employee assistance programmes and wellbeing resources Learning and development opportunities through structured training and career pathways Benefits may vary depending on role and location. Visit our careers site to read more about the benefits ICON offers. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here. Salary Range $110,520.00-$138,150.00 Are you a current ICON Employee? Please click here to apply ICON is an award-winning workplace that enables you to make a difference to patients lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide. You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live. If youre as driven as we are, join us. Youll be working in a great environment, with some of the brightest and the friendliest people in the sector, and youll be helping shape an industry. Didnt find the role you were looking for? Even if the perfect role isnt available right now, were always excited to connect with talented individuals. Register to our Talent Community to receive updates on roles that align with your career goals.