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.
What you will be doing:
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.
You are:
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
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits designed to be competitive within each country and focused on well-being and work-life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs
Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
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