Clinical Trial Associate - US Home-Based

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:

• Supports document collection, preparation, and adaption for submission to IRB/EC and Health Authorities, as applicable.
• Sets up systems.
• Supports vendor selection, TPRM process, SIM entries.
• IF and TMF management (country and site TMF); set-up and maintenance according to regulatory requirements; document oversight and tracking.
• Supports vendor set-up as applicable.
• Checks site “Green Light” completeness and ensures all documentation is in place for initial and subsequent drug release in collaboration with the local Qualified Person(s).
• Supports preparation and translation of ICF to local languages (including vendor management, if necessary).
• Supports preparation of patient facing material.
• Responsible for completeness of uploaded trial-related documents into CREDI/SUBWAY, including archiving of paper TMFs.
• Supports country SSU strategy in close collaboration with the SSU Team Lead and SSU Managers to ensure SSU timelines and deliverables are met according to country commitments.
• Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requir.nts.
• Provides logistic support to SSU CRA, CRA, CPM, SSU Manager during all phases of the clinical trial
• Implements innovative and efficient processes.

You are:

• Liasises with the Clinical Trial Team & has responsibility for the creation and tracking of clinical trial approvals, amendments, vendor tracking & access, eTMF Health checks to ensure inspection readiness.
• Along with ‘end-to-end’ CTA responsibilities, candidates must also have experience in Study Start Up Feasibility work.
• May assist with endpoint tracking or other specific tracking needs of the trial. 
• Must be detail oriented, organized, & have excellent communication skills.
• High school degree or equivalent; candidates should be made aware by the recruiters if no college degree their ability to move to other programs could be impacted; however, years of experience could make a difference.
• Minimum 2 years of experience

 
Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

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.

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.

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.