Clinical Trial Associate - Single Sponsor

Clinical Trial Associate - Single Sponsor

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

Clinical Trial Assistance services provides support for the CTM's, CRA's or Business Operations unit.

Responsibilities

• 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 Clinical Trial Managers and CRA's to ensure overall site management while performing trial related activities for assigned protocols.
• Support of the protocol specific training process, management of forms used to track, administer and document completion of protocol specific training.
• Further services/deliverables will include ensuring study related activities are compliant with Global Development SOPs, policies, code of Good Clinical Practice (GCP), Health Care Compliance requirements (HCC) and local regulatory requirements.
• Filing and maintenance of training materials in the Clinical Trial Learning & Development Training Library and the Trial Master File System at the direction of the Therapeutic Area (TA) Lead(s).

Deliverables

• Services rendered will adhere to applicable SOPs, WIs, policies, local regulatory requirements, etc.
• 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 CTM and CRA.
• 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 (GCO) or protocol specific training related documents (CTL&D). 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 CTM / CRA 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 reviews 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.

Requirements

• Degree in the life sciences
• Minimum of 1-2 years of previous proven CTA experience in a CRO or Pharmaceutical environment

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 designed to be competitive within each country and focused on well-being and work-life balance opportunities for you and your family.

• 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

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.