As a Clinical Trial Assistant you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
As a Clinical Trial Assistant you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. In this role, you will support the Local Trial Manager and CRA to ensure optimal management of all documents with logístical and administrative tasks related to trial start-up, execution and closing of clinical trials. Performs regulatory document review and approval, including site specific Informed Consents. Ensures trial related activities are in compliance with GCO SOPs, policies and local regulatory requirements.
**Your responsibilities will include**:
- Working with the Local Trial Manager and CRA 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).
- Ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes.
- Where applicable, works with investigational site staff to ensure accurate/complete regulatory documents are in place to expedite IEC/IRB or Health Authority (if applicable) approval process.
- Provide current and complete documents requested by the IEC/IRB and HA.
- Maintain 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.
**You will need**:
- Experience as 1-2 years
- A minimum of a BA degree is preferred.
- Skills set corresponding with preferentially relevant clinical trial experience or equivalent. Proficient in English.
- 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
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
