Clinical Trial Associate

ICON Strategic Solutions; Reading; On-site; GBP 28,000 - 38,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance

Retirement planning options

LifeWorks Global EAP

Life assurance

Job summary

ICON plc in Cambridge, UK, is seeking a Clinical Trial Associate to support trial start-up activities and regulatory submissions. You will liaise with sites, manage study documents, and maintain data in eClinical and other systems.

The role requires UK trial coordination experience, strong MS Office and EDC skills, and the ability to work in a fast-paced environment while ensuring data accuracy and compliance.

Qualifications

• UK-based clinical trial coordination/administration experience
• Proficient in MS Office and EDC systems
• Ability to work in a fast-paced environment with multiple electronic systems
• Accurate data entry and attention to detail
• Valid, current UK working eligibility

Responsibilities

• Create site folders, collate SIP documents and maintain study materials
• Coordinate feasibility questionnaires with clinical sites and track responses
• Enter and maintain local data in study management systems (eClinical, CDSS, SADMS)
• Prepare and submit regulatory documents for IRB/IEC submissions
• Organize Investigator meetings and monitor workshops within budget guidelines

Skills

Clinical trial coordination

MS Office

EDC systems

Multi-tasking

Attention to detail

Education

BA/BS/BSc degree

Nurse qualification

Tools

eClinical

CDSS

SADMS

Job description

Come and join our Cambridge office (UK) as a Clinical Trial Associate!

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.

We are hiring a Clinical Trial Associate to start immediately or with 1 month notice maximum to join our dedicated team in Cambridge (England/UK).

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

• 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
• 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
• Orders, processes and tracks Case Report Forms (CRF) and follows up on query resolution
• 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

What Is Offered

• Office-based in the Cambridge office (England/UK)
• Full-time
• Salary will be offered depending on the level of experience and skills
• Permanent contract of employment with ICON 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

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

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

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.

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