Job Description
As a CTA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing: - Assist the CTM and CTT with the coordination of the logistical aspects of the assigned trial(s), according to Good Clinical Practice (GCP) and the applicable Standard Operation Procedures (SOPs)
- Develop and adapt documents to trial specific requirements in collaboration with the CTM
- Assist with organizing (agenda, meeting minutes, follow-up on action items) trial specific meetings, including but not limited to trial team meetings and Investigator Meetings
- Coordinate the filing of Trial Master File (TMF) documents in the (electronic) Trial Master File (TMF) part of ECO by reviewing completeness and correct use of ECO. Follow-up with the CTT on findings and provide support on how to use ECO.
- Act as Business Administrator in the eTMF system, by maintaining records and supporting close-out activities (including archival preparation) in the eTMF system. This includes: managing study records, country records and site records.
- Assist the CTM/COL to ensure that the Trial Operations TMF Documents are properly filed and made ready for archiving.
- Provide logistical support to the CTT on vendor (e)TMF oversight activities
- Assist the Global Head of Trial Operations with the development of department template documents and the organization of the departmental meetings (agenda, meeting minutes, follow-up on action items)
- Assist with the preparation of trial reports for the CTT and keep them up-to-date
- Assist with signature collection of Confidentiality Disclosure Agreements, Purchase Orders, and insurance certificates in collaboration with CTM/ Vendor Management
- Assist with other Trial Operations related activities based on relevant experience
You are: - Speaks and writes English fluently
- Knowledge of International Conference on Harmonisation- Good Clinical Practice (ICH-GCP)
- Knowledge of Drug Information Association Trial Master File (DIA TMF) reference model
- Proficient in software applications such as Outlook, Word, Excel and PowerPoint
- Experience with tools and systems for managing clinical trials such as Microsoft Project
- Experience with trial progress and metric systems (eg Electronic Case Report Form (eCRF), Interactive Response Technology (IRT), Interactive Voice/Web Response System (IXRS), and Veeva Vault)
- Bachelor’s degree or University degree - medical, para-medical highly preferred
- Minimum of 1 year of experience in a similar position within Clinical Operations (CTA)
- Strong oral and written communication skills; excellent organization skills with the ability to prioritize tasks; ability to work both independently and as part of a multidisciplinary team
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:
At ICON, inclusion & belonging are fundamental to our culture and values. 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, colour, 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.
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.
Job Tags
Permanent employment, Flexible hours,