Senior Clinical Research Associate

📋 Description

• Execute site management tasks to ensure the client's Oncology site achieves success and remains in a state of constant inspection readiness.

• Serve as the main point of contact and facilitate smooth communication between the client's clinical trial team and the sites.

• Conduct both remote and on-site monitoring/co-monitoring visits (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 manage the submission/approval of visit reports.

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

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

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

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

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

• Support sites during the client's regulatory inspections.

• Participate in site identification; promote site feasibility and qualification advancements; and assist with site activation efforts.

• spearhead site engagement initiatives and cultivate relationships with key Oncology sites and networks.

⛳️ Requirements

• Bachelor’s degree (preferably in a scientific field).

• Over 5 years of experience in independently monitoring clinical trials through on-site and remote visits.

• Minimum of 2 years of experience monitoring solid tumor clinical trials.

• At least 1 year of experience in early development trial settings.

• Solid tumor clinical trial experience is mandatory.

• Experience with Veeva systems is highly preferred.

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

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

• Experience collaborating with sites from initial engagement through to close-out phases.

• Familiarity with site activation processes.

• Experience in training site staff.

• Background in supporting 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

• Various annual leave entitlements.

• A variety of health insurance options tailored to meet the needs of you and your family.

• Competitive retirement planning options to enhance savings and allow for confident planning for the future.

• Global Employee Assistance Programme, TELUS Health, providing 24-hour access to a global network of over 80,000 independent specialized professionals dedicated to supporting you and your family’s well-being.

• Life assurance.

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, and more.