As a Clinical Trial Assistant you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing: In this role you will provide administrative support for the Local Trial Manager (LTM)/Trial Manager (TM) and/or Clinical Research Associates (CRAs) including the management of all documents and logistical and administrative tasks related to trial feasibility, start up, execution and close out of clinical trials.
Ensures trial related activities are compliant with SOPs, policies, code of Good Clinical Practice (GCP), Health Care Compliance requirements (HCC) and local regulatory requirements.
Regulatory document review, including Informed Consent Forms.
Partners with the Local Trial Manager (LTM) and CRAs to ensure overall site management while performing trial related activities for assigned protocols.
Collects/prepares documents required for study, such as start-up/submission to the IEC/IRB and HA, in support of the LTM/TM/SM where applicable.
Collects and tracks financial disclosure information at appropriate timepoints in accordance with procedural documents.
Prepares study files for investigational sites and co-ordinates the development of associated documents and review them for completeness and accuracy.
Collects and files all documents throughout the trial and post-trial.
Uses appropriate systems to ensure file completeness at designated study milestones.
Coordinates archiving of paper study relevant documents/files.
You are: BA/BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience).
2-3 years of relevant clinical trial assistant's experience with previous experience on working on studies in Romania.
Proficient in English and Romanian language.
Previous experience in preparation and submission of documents to RA/EC, Experience in communicating with sites and local study teams Experience in eTMF Strong knowledge of 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.
#LI-DS1 #LI-Hybrid
