Ref #: 38728

Employment type: Permanent - Full-Time

Location: Cambridge

Posted: 28-Jul-2022


You will be ideally a clinical administrator with accomplished clinical trial coordination skills and the ability to multi-task within a fast-paced working environment.

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.

The CTA Site Management 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

• 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

CTA 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

• Full-time position office-based 3 to 4 days per week with the flexibility of 1 or 2 days working from home

• Salary will be offered depending on level of experience and skills

• Permanent contract of employment with company perks and benefits

• Company benefits to include 23 days annual leave plus UK bank holidays, pension, medical health insurance, etc.

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 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!

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.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

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.