Job description
CTA office-based in Cambridge
You will have the opportunity to join a well-established team of dedicated CTAs working on exciting clinical trials
The ideal candidates will bring clinical trials administration skills with the ability to multi-task and work within a close-knit team.
Key Activities:
- 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
- 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
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
- Office-based in the Cambridge office
- Full-time
- Salary will be offered depending on level of experience and skills
- Permanent contract of employment 100% dedicated to 1 single sponsor with company benefits
- 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 to fast-moving timelines 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!
Benefits of Working in ICON:
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
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.
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