Senior Clinical Research Associate

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest was founded in 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters is located in Toronto, Canada with additional offices in the United States, Europe, China and Taiwan.

Everest is known in the industry for its high-quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as  Senior Clinical Research Associate.

Key Responsibilities :

• Perform protocol / site feasibility and Pre-Study Visits to recommend qualified sites.
• Participate in Investigator Meetings, Clinical Research Associate (CRA) and Study Coordinator training sessions, and assist sites with study-related questions as needed.
• Perform Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits in compliance with the approved protocol and monitoring plan and according to ICH-GCP guidelines.
• Complete monitoring visit reports and follow-up letters, including summaries of the significant findings, deviations, deficiencies, and recommended actions to ensure site compliance.
• Assist with oversight visits and monitoring visit report review / approval of CRA I / II, evaluating their performance and providing feedback to their supervisor, if requested.
• Review ISFs to ensure essential documents are current and submitted to the TMF throughout the trial for reconciliation purposes. Ensure sites have submitted relevant documents to their Institutional Review Board / Ethics Committee as needed. The CRA is responsible for ensuring that the TMF is maintained in an inspection-ready state.
• Establish regular lines of communication and administer ongoing protocol / study-related training to assigned sites.
• Assist with site management tasks and ensure continuous data flow (i.e., on-time site data entry, query resolution, and source document verification). Assess the clinical research site’s patient recruitment / retention success and offer suggestions for improvement.
• Ensure proper handling, accountability, and reconciliation of all investigational products, medical devices, and clinical trial supplies.
• Prepare sites for inspections / audits conducted either by regulatory authorities, Sponsors, or Contract Research Organizations.
• Submit accurate and on-time expense reports.
• Assist the Clinical Operations team with additional related tasks as needed.
• Complete timesheets as requested and on-time.

Qualifications and Experience :