Senior Clinical Research Associate

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

📋 Description

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

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

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

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

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

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

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

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

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

• 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.

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

• Lead initiatives to engage sites and cultivate relationships with key Oncology sites and networks.

⛳️ Requirements

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

• Over 5 years of experience in independently monitoring clinical trials, 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 trial oversight.

• Proven experience in solid tumor clinical trials is required.

• Proficiency in utilizing Veeva systems is highly preferred.

• Demonstrated capability in developing and maintaining site relationships while ensuring compliance.

• Expertise in GxPs and Oncology monitoring techniques, including Risk-Based Monitoring, as well as relevant terminology.

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

• Experience in site activation processes.

• Background in training site staff is essential.

• Experience in supporting sites and/or sponsors during regulatory inspections.

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

• Residing in Alberta and willing to travel up to 75%.

🏝️ 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.