Global Clinical Trial Associate - Medical Affairs

Overview

As a Clinical Trial Assistant you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

What you will be doing:

• 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.
• 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.
• 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.
• 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.
• Ensures audit and inspection readiness.
• Provides 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.
• Collects/prepares documents required for study, such as start-up/submission to the IEC/IRB and HA.
• Collects and tracks financial disclosure information at appropriate timepoints.
• Prepares study files for investigational sites and co-ordinates the development of associated documents.
• Provides updates to study specific internal data repositories.
• If requested, manages study budget including Affiliate spend, vendor management.
• If requested, organizes training for SM(s) and/or SIV/small investigator meetings.
• If applicable, region specific deliverables will be specified.

Qualifications

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.
• Legally authorized to work in the United States and should not require sponsorship for employment visa status.

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 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
• Competitive retirement planning offerings
• Global Employee Assistance Programme, offering 24-hour access to a global network of professionals
• Life assurance
• Flexible country-specific optional benefits

At ICON, diversity, 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.