Clinical Trials Assistant - Swansea, United Kingdom - Cyden

Description

Clinical Trial Assistant:

Swansea


About CyDen

CyDen is a British Health and Beauty company and a leading developer and manufacturer of Intense Pulsed Light (IPL) hair removal devices for use in the home.

Our electronic beauty products are distributed worldwide into household and medical markets under globally recognised brand names.

CyDen provides a dynamic and exciting
fast-paced working environment, supported by an excellent and welcoming team of employees. We now have an opportunity for someone to join us in the role of
Clinical Trials Assistant.

The Role

The role is very practical, and you will spend most of your time operating to a very high degree of rigour, under the constraints of time, within our clinical suites. You must be comfortable working in this type of environment.

The training programme is prescriptive and demanding. You will be provided with materials and resources, in addition to training videos. You will be expected to undertake several informal and formal
competency tests throughout your probationary period. Your mentor will provide continued support.

Following extensive training you will become a key member of the clinical research team responsible for the
execution of daily clinical research activities according to Standard Operating Procedures (SOPs), Good Clinical Practice and the applicable Clinical Trial directives and legislation.

You will be solely responsible for performing all aspects of the patient appointment, which will consist of delivering
treatments with the investigational product(s),
capturing high quality real-time photographs, and
performing
non-invasive skin measurements.

You will be heavily involved in all aspects of the clinical trial process from study design, recruitment, execution through to routine close-out activities.

The role will involve
working independently across multiple clinical suites, and alongside other CTAs in an open plan office; the culture is very friendly, and team based.

You will be expected to
liaise with study participants both verbally and by written forms of communication, delivering detailed and accurate information about upcoming clinical investigations.

You will participate in devising new training resources, including training videos. You may also be asked to participate in footage for marketing and commercial needs.

The nature of all work is such that it must be undertaken within the clinical trials facilities and is on a flexible shift pattern that includes evening work.

Working under the direction of the Principal Investigator, and reporting to the Clinical Operations Co-ordinator, your responsibilities will include but are not limited to:

• Preparation and review of study related documents prior to study commencement
• Maintaining an uptodate and accurate appointment schedule
• Ensuring completion of the informed consent process
• Working to multiple study protocols, in different stages of a trial development (start up, recruitment, maintenance, closeout)
• Executing clinical research activities to a very high degree of rigour, including performing treatments with the investigational devices, and capturing high quality, realtime photographs
• Ensuring accurate and complete Case Report Form entry during trial execution
• Monitoring patient status and safety.
• Accurately transcribing raw data and ensuring records are maintained.
• Monitoring and replenishing clinical suite supplies/consumables.
• Prompt reporting of any concerns arising during a study
• Monitoring and reconciling Adverse Events and Adverse Device Effects
• Preparing Standard Operating Procedures as required

The Person

You must be comfortable speaking to participants about the company and it's product portfolio, and the nature and detail of the trials being undertaken.

Being flexible and adaptable to change is essential, working to the needs of the business and able to work the varied hours required.

Essential requirements:

• Good secondary or vocational qualifications (e.g., 'A'level, BTEC Certificate) including GCSEs in Maths & English
• Strong attention to detail
• Experience of working in a structured, rigorous manner.
• Able to work to tight deadlines.
• Receptive to constructive feedback
• Dynamic and able to work effectively in a fastpaced environment
• Thrives when working under pressure
• Highly organised and proactive
• A good team player with a strong sense of responsibility.
• Selfmotivated / candoattitude
• Proficient using Microsoft Packages [Word, Excel, PowerPoint, Teams, Outlook]

Desirable requirements:

• HNC/HND or equivalent in a science related discipline
• Experience of undertaking clinical trials using Good Clinical Practice.
• Excellent communication (written and spoken) and interpersonal skills.
• A high level of numeracy
• Strong problemsolving skills
• The ability to maintain utmost confidentiality in all work matters.
• The ability to