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Note: The job is a remote job and is open to candidates in USA. ICON plc is a world-leading healthcare intelligence and clinical research organization. The Clinical Trial Assistant will manage documents and logistical tasks related to clinical trials, ensuring compliance with regulatory requirements and supporting trial managers in various activities.
Responsibilities
Services rendered will adhere to applicable client SOPs, WIs, policies, local regulatory requirements, etc.
Comply 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 time points 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, organize training for SM(s) and/or SIV/small investigator meetings.
If applicable, region-specific deliverables will be specified.
Skills
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 preferred
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
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
1-2 years of relevant clinical trial experience with associated skill sets preferred
Experience in VeevaVault TMF is desirable
Benefits
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.
Company Overview
ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services. It was founded in undefined, and is headquartered in Dublin , GB, with a workforce of 10001+ employees. Its website is https://www.iconplc.com/services/strategic-solutions/.
