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Clinical Trials Assistant
1 week ago
We are hring a CTA office-based 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.
The Role and Responsibilities
- Responsible for study startup 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
- Coordinates entry and maintain local data into study management systems (eClinical, CDSS/CDSSR, SADMS, etc.) 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
- 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, etc.
What is required:
- Ideally BA/BS/BSc or qualified nurse
- UKbased clinical trial coordination/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 fastpaced working environment using different electronic systems
- Excellent and accurate attention to detail when entering data onto systems/database
- Valid, current UK working eligibility
What is Offered
- Officebased in the Cambridge office (England/UK)
- Fulltime
- Salary will be offered depending on level of experience and skills
- Permanent contract of employment with us and 100% dedicated to 1 single sponsor
Salary:
From £20,000.00 per year
Benefits:
- Employee discount
- Life insurance
- Referral programme
Schedule:
- Monday to Friday
Experience:
- line management: 1 year (preferred)
- clinical project management: 1 year (preferred)
Work Location:
In person
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