Clinical Trials Assistant

3 weeks ago

Swansea, United Kingdom Cyden Ltd Full time

**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 up-to-date 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, close-out)
- Executing clinical research activities to a very high degree of rigour, including performing treatments with the investigational devices, and capturing high quality, real-time 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 fast-paced environment
- Thrives when working under pressure
- Highly organised and proactive
- A good team player with a strong sense of responsibility.
- Self-motivated / can-do-attitude
- 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 problem-solving skills
- The ability to maintain utmost confidentiality in all work matters.
- The ability to adapt to changing priorities, taking on additional tasks where required.
- The ability to work effectively as both an individual and as part of a team.

**Salary and Benefits**
- Competitive salary
- 25 days annual holiday entitlement, plus bank holidays
- 5% Emr Pension contribution
- Cycle to Work scheme
- Free parking
- Internal and external training (ICH GCP, First Aid, AED)
- EAP Scheme

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