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Salary not available. View on company website.
ICON PLC, Newtown, Cambridge
- Onsite working
- Full time
- Permanent
Full Job Description
You will have the opportunity to join a well-established team of dedicated CTAs providing key clinical trial administration support to exciting clinical trials. To succeed, you will demonstrate good UK clinical trial coordination with the ability to multi-task and work in fast-paced working environments. The Role and Responsibilities
- Interacts with Clinical Research Services Manager for project or study related work
- Supports the execution of clinical studies 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 including setting up new studies in eClinical
- 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
- Organise and participate in Investigator meetings and monitor workshops as required within budget guidelines
- Processes, reconciles, distributes and tracks essential documents and submits them to RIM/EPIC or local archive in compliance with client's 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 organise shipments (including but not limited to frozen samples) as required
Ideally BA/BS/BSc or qualified nurse - UK-based clinical trial co-ordination/administration experience gained within the clinical research industry or within NHS trust/hospital setting
- Proven ability to work efficiently and accurately with MS Office and EDC systems
- Ability to work effectively within a fast-paced working environment using different electronic systems
- Excellent and accurate attention to detail when entering data onto systems/database
- Valid, current UK working eligibility
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
Salary will be offered depending on the level of experience and skills - Permanent contract of employment with us and 100% dedicated to 1 single sponsor, 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. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include:
- Annual leave entitlement
- Health insurance offerings to suit you and your family's needs
- Competitive retirement planning offering 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 Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits At ICON, 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. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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ICON PLC
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