As a Clinical Trial Assistant, you will be joining the world's largest and most comprehensive clinical research organization, powered by healthcare intelligence.
What you will be doing:
Perform investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, and in-house site management activities in accordance with the Sponsor and/or PRA protocol, standard operating procedures (SOPs), ICH/GCP guidelines and all applicable regulatory requirements.
Perform a variety of routine essential document collection, review, and negotiation to ensure successful site activation and maintenance and close out tasks under general supervision.
Perform recruitment of study sites, ensuring activities, documents, and all other clinical data are accurately tracked and documented for the project lifecycle.
Escalate issues as needed.
Complete submissions and notifications to regulatory authorities, ethics committees, and other bodies.
May serve as a patient management associate (conduct patient interviews, answer questions, follow up on issues).
Perform and document clinical data review and query creation, query resolution, offsite central monitoring contacts/visits, and site management communications as outlined in the study plans (and/or other processes).
Set up and maintain study documentation in applicable systems, e.g., clinical trial management system (CTMS), TMF system, and applicable site/sponsor systems according to project protocol, applicable SOPs, and project plans.
You are:
Undergraduate degree or its international equivalent in clinical, science, or health-related field.
Prior experience using computerized information systems.
Clinical trials support or pharmaceutical industry experience preferred.
Advanced English; fluent in host country language required.
Experience with PC-Windows, word processing, and electronic spreadsheets preferred.
Office-based or clinical employment experience preferred.
Knowledge of ICH and local regulatory authority drug research and development regulations preferred.
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 maximize 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 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.
At ICON, diversity, inclusion & belonging are fundamental to our culture and values.
Our rich diversity makes us more innovative, helping 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 organization.
We're dedicated to providing an inclusive and accessible environment for all candidates.
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