This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
As a CRA you will be joining the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.
Job Responsibility:
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
Operational Excellence: Contribute to sponsor goals Promote operational and scientific excellence Identify opportunities and best practices with local/regional partners that will contribute to the overall operational effectiveness
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 such as Intralinks
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
Requirements:
Bachelor's degree in a scientific or healthcare-related field
Minimum of 2 years of experience as a Clinical Research Associate
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines
Strong organizational and communication skills, with attention to detail
BA/BS/BSc in the sciences or nursing equivalent
A trained CRA with on-site monitoring experience
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
Nice to have:
Experience in phase II and phase III trials (preferred)
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)
What we offer:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others