Senior Global Clinical Trial Assistant (EST-based remote) - Oncology

Clinical Trial Associate

The Clinical Trial Associate will be responsible for setting up, tracking and maintaining Clinical Site related documents. You will help manage and review regulatory documents as well as maintain the Local Study File. Assist with coordinating the distribution, retrieval and review of regulatory documents required for the initiation of the Clinical Study, through maintenance, and close-out.

Performs the role of Clinical Trial Assistant (CTA) supporting the Local Trial Manager and Site Manager to ensure optimal management of all documents with logistical and administrative tasks related to trial start-up, execution and closing of clinical trials. Performs regulatory document review and approval, including site specific Informed Consents. Ensures trial related activities are in compliance with GCO SOPs, policies and local regulatory requirements. May contribute to process improvement, training and mentoring of other CTA’s.

Responsibilities

• Responsible for study start-up activities, including creating site folders, collating, preparing and maintaining (e)SIP documents, updating systems
• Liaise with clinical sites to collect, review and track feasibility questionnaires
• Co-ordinates entry and maintain local data into study management systems (eClinical, CDSS / CDSS-R, SADMS, etc) including setting up new studies in eClinical
• Act as a back-up for other Supplier CTAs
• Ensures collection, review, track and provision of appropriate clinical documents to support regulatory submission and to perform IRB / IEC submissions including when appropriate preparation and submission of all documents to the central and / or local committee
• Track and maintain adequate study related supplies in the office and facilitate their distribution to sites, including preparing and distributing Study File Binders, study drugs and Site Initiation presentations / materials
• Organize and participate in Investigator meetings and monitor workshops as required within budget guidelines
• Provides support to responding to local audits and inspections
• Processes, reconciles, distributes and tracks essential documents and submits them to RIM / EPIC or local archive in compliance with SOPs
• Has ability to process SIPs and forward to Regulatory / RIM within 5 business days from the date of SIP approval. Follow eSIP process
• Completes tracking documentation as applicable including but not limited to spreadsheets, study and contract tracker
• Orders, processes and tracks Case Report Forms (CRF) and follows up on query resolution if required to do so
• Manage local distribution of Investigator Brochure
• Prepare and review site communication documents; facilitate mass mailings / faxes
• Provide administrative support such as word processing, photocopying, faxing, filing, managing correspondence, presentations preparation, basic computer software support
• Set-up / maintain courier accounts and organize shipments (including but not limited to frozen samples) as required
• Interacts with Clinical Research Services Manager for project or study related work
• Supports the execution of clinical studies
• Responsible for study start up activities
• Tracks study related documents
• Manages logistics and document exchange between clinical sites and sponsor
• Actively contributes to results oriented department goals
• Drives continuous improvement of GCSM
• Promotes operational and scientific excellence within local GCSM
• Identifies opportunities and best practices with local and regional partners that will
• contribute to overall operational effectiveness
• Responsibilities may include Lead CTA activities as required. Activities may include but are not limited to :
• Works with the CTA Line Manager to complete delegated tasks from the Quality Oversight Plan
• Works with the CTA Line Manager and sponsor groups to develop policies and practices relevant to the CTA group
• Provides mentorship and training to newly hired CTAs and other CTAs as required
• Participate, contribute and collaborates to share best practices across the program including action planning and support for addressing and resolving challenges

Requirements