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As a Clinical Trial Assistant Sponsor dedicared you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
Partners with the LTM and Site Manager to ensure overall site management and adherence to internal SOPs, policies and local regulatory requirements.
Supports the local study team in performing site feasibility and/or country feasibility.
Maintains site level protocol information in Trial Management Systems (e.g. CTMS).
In liaison with the LTM, ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes.
works with investigational site staff to ensure accurate/complete regulatory documents are in place to expedite IEC/IRB or Health Authority approval process.
Supports the Trial Manager and Clinical Monitor in providing the current and complete documents requested by the IEC/IRB and HA.
Supports the TM & CM in collecting and maintaining all documents throughout the trial and post-trial in both eTMF (i.e., IF/LAF sections) and paper files.
Distributes, collect, review, and track regulatory documents, agreements and training documentation.
Collects and tracks Financial Disclosure information at appropriate time points.
May contribute to process improvement including, but not limited, to representing functional area in process initiatives and contribute to optimization of daily processes.
May be assigned as a coach and mentor to a less experienced CTA.
You are: Skills set corresponding with preferentially 2+ years relevant clinical trial experience or equivalent.
Proficient in English language.
Strong knowledge with MS Office (Word, Excel, Access, Outlook , Explorer and PowerPoint)
Strong interpersonal and negotiating skills.
Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.
Perform activities in a timely and accurate manner.
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
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
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. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. 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 through the form below.
https://careers.iconplc.com/reasonable-accommodations
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
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