Ref #: 32137

Employment type: Permanent - Full-Time

Location: Ireland

Posted: 16-Sep-2021


Ireland-based CRAII/Senior CRA responsibilities:
• Facilitate subject enrolment at the site level with focused patient recruitment strategies and action plans;
• Identify site needs and site-related issues, escalate and/or initiate corrective actions when necessary, providing solutions for site staff to facilitate the clinical trial process;
• Respond to site-related queries and escalate site-related issues with operational site management responsibility;
• Perform investigational product accountability and reconciliation, maintain site study supplies, and facilitate the resolution of clinical queries to investigative staff;
• Build and maintain solid and long-term professional relationships with investigators and site staff;
• Ensure clinical study sites are conducting clinical trials in compliance with the respective protocol, our client's SOPs and applicable ICH/GCP guidelines and regulations;
• Assist in preparing sites for audits, review audit reports and contribute to resolving findings;
• Ensure appropriate safety reporting as well as tracking and reporting of adverse events (AEs and SAEs) and to verify case reports and source documentation;
• Input and maintain electronic site management systems, provide input into clinical monitoring plans, input into case report forms and study-related documents as requested.

Ideal candidate type;

• Previous CRA experience of commercial phase II and phase III studies
• Proven external/independent clinical trial monitoring experience gained in the UK/Ireland
• Full Ireland working eligibility
• Able to work effectively within fast-paced working environments
• A minimum of 1 year experience but preferably 2 years independent monitoring experience.
• Expect 5-8 site visits/month.