Clinical Set Up Specialist

Job title: Clinical Set up Specialist

Location: Central London (6 days homeworking offered per month)

Fully sponsor dedicated

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.With our patients at the center 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.

Working fully embedded within one of our biggest sponsors, who are rated top 5 globally, with the support of ICON right behind you, you’ll be at the heart of our client’s innovation. 

The Clinical Set Up Specialist is responsible for providing an efficient and professional ethics and R&D set up service within required timelines according to company SOPs and ICH GCP guidelines and to provide advice and knowledge to Project Managers and clinical associates regarding the ethics / regulatory processes in the UK. 

You will be responsible for:

• Accountable for rapid study set up for all clinical trials across TMO and ensures that TMO are provided with a first in class study set up service.
• Works closely with Clinical Set Up and Logistics Manager to identify process improvements for a more efficient service of ethics and trial set up.
• Advises clinical project teams and ICRO Department with regards to new processes and procedures concerning ethics and R&D processes and advises Project Managers and field based CRAs on submission timelines.
• Proof reads ethics submissions and documentation for Clinical Project Managers and liaises with Medical Advisers when needed.
• Takes the lead on new Regulatory department processes and trains team appropriately.
• Performs site monitoring activities such as unmasked monitoring and site drug supply management when required
• Collates, prepares and submits MREC and HRA applications to the earliest possible review meetings following NRES and ICH GCP and collates, prepares and completes R&D applications for R&D submissions during trial set up period.
• Is responsible for contract / budget negotiations with R&D/PCTs for TMO clinical trials and prepares contracts for Contract Manager review.
• Responsible for clinical trial set up, facilitates preparation and collection of country and site level documentation to ensure drug shipment without delay.
• Is accountable for timely distribution of trial safety data for specified products as per regulatory requirements to ethics and R&D departments and well as the submission progress and end of study clinical reports to the sponsor SOPs and NIPs and local authority requirements
• Liaises with Global interfaces and other departments to ensure correct reporting documentation is received for submission
• Trains sites as appropriate in the set up and use of vendor systems and equipment

You must have:

• A degree in a scientific or health care discipline or equivalent desirable
• Relevant experience within the Pharmaceutical Industry / CRO environment with a good knowledge of Clinical Research processes including ICH GCP Experience within UK Ethics/Regulatory environment essential Desired experience as a Senior Clinical Support Associate or Ethics Committee Adviser or equivalent e.g. CRA, Research Coordinator PC Literate - Intermediate Word, Excel, PowerPoint, Lotus Notes

Benefits of Working in ICON:

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, 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.