Senior Clinical Research Associate

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Execute site management tasks to enhance the success of the client's Oncology site and ensure a constant state of readiness for inspections.

• Serve as the main point of contact, facilitating effective communication between the client's clinical trial team and the sites.

• Conduct both remote and on-site monitoring/co-monitoring visits (such as Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits) to guarantee data integrity and the safety of subjects in the client's trials.

• May oversee activities to evaluate monitoring quality and provide training/mentorship to less experienced Clinical Research Associates (CRAs).

• Timely document monitoring activities and submit or approve visit reports.

• Manage the collection of essential site documents and reconcile the Trial Master File (TMF) with site files.

• Assist sites with submissions to local Institutional Review Boards (IRBs) and Ethics Committees (ECs) and confirm necessary approvals.

• Regularly assess site Key Risk Indicator (KRI) metrics, issues, and action items to identify trends and ensure swift resolution.

• Independently analyze root causes and create/implement site Corrective Action and Preventive Action (CAPA) plans.

• Provide training to ensure that sites adhere to the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and relevant regulations.

• Support sites during the client's regulatory inspections.

• Contribute to the identification of sites; drive the progress of site feasibility and qualification; and assist in site activation activities.

• Lead initiatives for site engagement and build relationships with key Oncology sites and networks.

⛳️ Requirements

• Bachelor’s degree in a scientific field is preferred.

• Over 5 years of experience monitoring clinical trials, independently conducting both on-site and remote monitoring visits.

• At least 2 years of experience monitoring solid tumor clinical trials.

• Minimum of 1 year of experience in early development trials.

• Solid tumor clinical trial experience is mandatory.

• Proficiency in using Veeva systems is highly preferred.

• Proven track record in developing and maintaining site relationships and ensuring compliance.

• Expertise in GxPs and Oncology monitoring techniques (including Risk-Based Monitoring) and relevant terminology.

• Experience collaborating with sites throughout all phases, from initial engagement to close-out.

• Familiarity with site activation processes.

• Experience training site personnel.

• Experience assisting sites and/or sponsors during regulatory inspections.

• Preferred experience working within a Functional Services or in-house monitoring model.

• Willingness to travel up to 50%.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Comprehensive health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.