Clinical Research Assistant
5 months ago
**Company Description** Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate.**
**Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies.**
**Eurofins Alba is a contract research organisation based in the centre of Edinburgh. We are contracted by various cosmetic and personal care product manufacturers or retailers to test their products. We test the products to confirm their safety and efficacy in use - to ensure the products are safe and that they work. We have a database of human volunteers who take part in our tests who either attend our test centre in Edinburgh or test products from their own home. Products can range from shampoos through to make up, with many different study types to help support marketing claims such as “Moisturises for 12 hours”.**
**Job Description** This is a fulltime, permanent position working a 35 hours week - Monday - Friday 09:00 - 17:00.**
The Clinical Research Assistant will be a member of the “Technical” research team at Eurofins Alba Science Ltd.:
- Assist with a variety of research studies, particularly in claim substantiation, efficacy and safety, working within study protocols and to ICH/GCP standards.
- Provide support to volunteers, study team staff and more senior colleagues. The role will involve maintaining systems and/or undertaking routine tasks that support the working of teams, processes and/ or studies.
- Require the relevant knowledge which may be gained through experience and on-the-job training.
- Complete all documentation relating to volunteer participation, including database demographic data records, Case Report Forms (CRF’s) and electronic research records.
- Deal with telephone enquiries from volunteers, external and internal customers giving responses where this is within the post holder’s area of knowledge and ensuring that appropriate personnel are informed if appropriate in order for further actions to be taken.
- Contacting volunteers to recruit them for specific studies, scheduling times for their visits and performing the accordant administration on the database.
- Interact with study participants in relation to the requirements of the study and be able to work without supervision in some areas.
- Assist the Quality Manager, Department Head(s) and or the Project Manager to ensure that the study is conducted efficiently and in line with GCP.
- Responsible for the testing, preparation, storage and shipping of research samples to include:
- Technical conduct of studies in accordance with relevant protocols.
- To assist with ensuring that all test materials and other consumables are available for the proposed study commencement and to ensure satisfactory disposal of test materials on study completion.
- Dispensation and preparation of study test materials employing correct sample containers, sample labels, etc in line with standard operating procedures and the study protocol.
- Identify eligible volunteers for recruitment to participate from volunteer database or screening records.
- Preparation, assessment and testing of volunteers participating in research, including observations & recording of skin responses, instrument data and other appropriate measurements as required.
- Be able to instruct study participants on the study procedures and use (where appropriate) of test materials/devices.
- To assist with ensuring that all aspects of the study schedule are adhered to and that results are available (to other teams) on time.
- Maintain required records of study activity including case report forms, test material dispensation records, or regulatory forms.
- Responsible for the monitoring and maintenance of clinical stock levels and clerical store levels, ensuring effective and economic use of resources.
- To prepare data for reporting and study files for archiving.
- To assist with responding to QA audits throughout the life cycle of studies including study inspections, data, and report audits.
**Qualifications**
- Has the ability to communicate directly with potential volunteers and study participants being able to answer questions about the study within their area of knowledge, and to refer to more senior team members when appropriate.
- Ability to implement local, national and international quality standards for clinical trials including implementation of ICH-GCP (International Conference on
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