Clinical Research Associate - III

About the role

The Clinical Research Associate (CRA) is the main contact between the investigational sites, Novotech and the sponsor. The role protects the rights and wellbeing of trial participants and ensures that reported trial data are accurate, complete and verifiable from the source documents. It is a site relationship management position covering quality study management and monitoring at country and site level, with moderate oversight from the line manager or project manager.

Key responsibilities

• Build relationships with Principal Investigators, study coordinators, pharmacists and other site personnel, and foster internal and external customer relationships
• Prepare site documents with the in-house CRA and Regulatory Start-Up Associate, and support ethics and regulatory submissions
• Ensure participant recruitment meets site targets and drive site recruitment and engagement initiatives
• Monitor sites according to ICH GCP and the Clinical Monitoring Plan, including site selection, initiation, monitoring, close-out, unblinded pharmacy visits and co-monitoring, onsite or remote
• Check consent forms, patient eligibility, protocol and drug compliance, and report adverse events and safety issues promptly
• Verify accurate and complete trial data, resolve CRF queries within study timelines, and ensure study drugs are stored, dispensed, accounted for and reconciled
• Keep the Trial Master File up to date, support sites being audit and inspection ready, and keep clinical trial management systems current
• Provide site updates and escalation of key issues, and collaborate with the IHCRA and Site Contract Associates on site payments
• Support the project manager with study plans and templates, and assist in reviewing and developing clinical SOPs
• Work with business development to share site feasibility information and highlight opportunities

Required profile

• Graduate in a clinical or life sciences-related field; relevant experience in allied professions may also be considered
• At least 3 years of Clinical Research Associate experience
• Experience in the research, pharmaceutical industry or a related field

Required skills

• Good time management and attention to detail
• Team player and computer literate
• Thorough understanding of ICH GCP, the Declaration of Helsinki and local guidelines