Clinical Trial Assistant - Home Based

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:

Services/deliverables include 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 GCO SOPs, policies, code of Good Clinical Practice (GCP), Health Care Compliance requirements (HCC) and local regulatory requirements. Further services/deliverables will include technical regulatory document review, including Informed Consent Forms. Partners with the Local Trial Manager (LTM) and Site Manager (SM) to ensure overall site management while performing trial related activities for assigned protocols.

• Services rendered will adhere to applicable client SOPs, WIs, policies, local regulatory requirements, etc.
• Complies with relevant training requirements.
• Provides the following deliverables: tracks progress of the clinical trial, manages study data, budget, investigational products, mailings and correspondence and other relevant tasks in support of the LTM/TM and SM.
• Maintains trial, country and site level protocol information in trial management systems, including but not limited to relevant systems to ensure appropriate safety update distribution.
• Ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site(s) within required timeframes.
• 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.
• Ensures audit and inspection readiness.
• Provide process improvement suggestions if applicable.
• Negotiates site requested changes to the confidential disclosure agreement; checks investigators and IEC/IRBs against exclusion databases, IEC/IRB registrations and alerts as applicable; and other relevant tasks in support of study feasibility and site assessments.
• 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.
• Provides updates to study specific internal data repositories to ensure availability of trial documents to the study team.
• If requested, manage study budget including Affiliate spend, vendor management (including reconciliation of invoices and final budget), liaising with Accounts Payable as necessary.
• If requested, organizes training for SM(s) and/or SIV/small investigator meetings.
• If applicable, region specific deliverables will be specified.

You are:

• BA/BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience).
• 1-2 years of relevant clinical trial experience with associated skill sets.
• Proficient in English language (spoken and written).
• 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.
• Experience in VeevaVault TMF is desirable
• To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status

Home Based in US 

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.