Ref #: 27258

Employment type: Permanent - Full-Time

Location: Australia

Posted: 24-Mar-2021

Description

If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in the pharmaceutical Industry, then here is your chance. We are hiring a Clinical Research Associate II to work closely with our client, a leading pharmaceutical company.

Overview
As a Clinical Research Associate (CRA) you will coordinate all aspects of the clinical monitoring and site management process in accordance with regulatory guidelines, local regulations and standard operating procedures. In this role you will be a decision maker, solving problems independently or as part of the client and ICON team.
You will be managing competing priorities, supporting the on-site team, ensuring investigators follow the clinical trial protocol, providing training, and most importantly, motivating the team to ensure high quality results.

Key responsibilities
• You will monitor multiple Phase I, II, III & IV clinical trial sites, across different therapeutic areas. Assist other CRAs with co-monitoring activities both remote and on-site.
• You will utilise your customer service mindset with your sites focusing on delivering value, building loyalty and trust to create a positive impact and strong relationship with investigators and study coordinators where respect, knowledge and commitment to ICH/GCP guidelines are key to successful trial conduct.
• As the CRA you are the main sponsor representative, providing key project updates. You will collaborate with the team, developing commitment to study timelines and objectives through regular visits with site staff in-person and remotely.
• You will be first to review "source to CRF/eCRF," ensuring patient safety and data integrity aspect of the study.
• As the first point of contact for study sites, escalating any concerns/issues to other departments including Safety, Investigational Medicinal Product, Local Study Managers and management team as appropriate.
• Additionally, you will oversee the sites' adherence to GCP/ICH practices, ensuring quality of study conduct.
Required experience and qualifications
• Bachelor’s Degree (or equivalent) with 2-4 years of relevant healthcare experience in the pharma or clinical research industry. Minimum 6-12 months of monitoring and site management experience
• Scientific background
• Proficiency with medical terminology
• Working knowledge of Local Regulations
• A demonstrated working knowledge of ICH/GCP Guidelines
• Excellent record-keeping skills and attention to detail
• Experience conducting Site Selection, Initiation, Routine Monitoring and Close Out Visits both remotely and on-site
• Fluent in English, both written and oral
• Strong technical skills with CTMS, eCRF, eTMF
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