Job Description

Job Description

** Local travel or a short direct flight**

** no DOS metric**

What you will be doing:

• Conduct clinical trial site visits including evaluation, initiation, monitoring and close out
• Oversee and report on the conduct of clinical trials at a site level including and on-line site visit reports and updates to electronic management systems
• Proactive site management including:
• Building and maintaining solid and professional relationships with site staff
• Facilitating subject enrolment incorporating recruitment strategies and action plans at site level
• Maintaining site audit/inspection readiness
• Ensuring appropriate safety reporting and use of on-line safety reporting/reviewing systems
• Verification of electronic case report form data against written and electronic source documentation as per study schema/monitoring plan
• Responding to site queries and escalating issues in accordance with processes and timelines
• Conducting IP accountability and reconciliation
• Facilitating implementation of new technologies and systems at clinical sites (Electronic Data Capture, eSAE reporting)
• Maintenance of site study supplies

You are:

• BA/BS/BSc in the sciences or nursing equivalent
• A trained CRA with at least 2 years of on-site monitoring experience in phase II and phase III trials
• Working knowledge of Electronic Data Capture (preferred)
• Experience/working knowledge of the oncology disease area (preferred)
• Experience of Centralized/Risk Based/Targeted monitoring (preferred)
• Experience of working within a metric based environment (preferred)
• Comprehensive knowledge and understanding of ICH-GCP
• Fluent oral (face to face and telephone) and written English language skills
• Able and willing to travel up to 60% of the time or as per local requirements
• Possession of a full driver’s license
• Able and willing to work from a designated and appropriate home office as per local requirements
• Willing to attend and contribute to team meetings including mandatory training (remote/off-site)
• Competent computer skills including working knowledge of common software packages
• Working knowledge of trial management databases and on-line systems
• Able to attend a 1 week face to face in-house training course as part of on-boarding training
• Able and willing to work on several protocols/therapy areas

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. Our benefits are designed to be competitive within each country and are 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

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