We currently have an excellent CTA career opportunity with a top global company who is seeking a new team member to consolidate their dedicated CTA team in Cambridge (UK).
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.
If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in the pharmaceutical Industry, then here is your chance to join us as a CTA.
You will have the opportunity to join a well-established team of dedicated CTAs working on exciting clinical trials. To succeed, you will bring clinical trials coordination with the ability to multi-task and work in fast-paced working environments.
The Role and 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/CDSSR, 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
- Organise 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 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
Responsibilities:
- 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 the company
- 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
What is Offered
- Office-based in the Cambridge office (England/UK)
- Full-time
- Salary will be offered depending on level of experience and skills
- Permanent contract of employment with us and 100% dedicated to 1 single sponsor
What is 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
Please contact me with your most recent CV today!
Onsite:#LI-Onsite
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. 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
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
