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For Companies At a Glance
- Tasks: Support clinical trials and manage documentation while ensuring regulatory compliance.
- Company: Join Terumo Aortic, a leader in medical technology focused on innovation and patient care.
- Benefits: Gain valuable experience in a dynamic environment with opportunities for training and development.
- Why this job: Be part of impactful clinical research that contributes to healthcare advancements and patient outcomes.
- Qualifications: Administrative experience and strong organisational skills are essential; medical device knowledge is a plus.
- Other info: This is a 12-month fixed-term contract with potential for growth in the clinical field.
The predicted salary is between 30000 - 42000 £ per year.
Overview
Terumo Aortic are currently recruiting for a Clinical Research Assistant to join their busy Clinical Affairs department on a fixed term contract for 12 months. The successful candidate will support the Clinical Affairs Department in maintaining clinical trials and Post Market Clinical Follow-up (PMCF) Registries and Investigations/Studies. This role involves performing administrative tasks, assisting in clinical investigations, and ensuring compliance with regulatory standards. The ideal candidate will contribute to specific project elements and aid in achieving department deliverables.
Key Duties
- Clinical Trials and PMCF Support:
- Assist in the maintenance and management of clinical trials and PMCF registries.
- Support defined elements of clinical investigation/study projects.
- Ensure adherence to ICH GCP, Medical Device Regulation, ISO 14155, and other regulatory requirements.
- Administrative Tasks:
- Perform various administrative duties within the Clinical Affairs Department as required.
- Maintain department files and documentation.
- Implement and maintain the Trial Master File (TMF/eTMF) and any applicable Clinical Trial Management Systems (CTMS).
- Compliance and Training:
- Undertake training to develop and maintain competency in regulatory compliance.
- Create, develop, and maintain departmental Standard Operating Procedures (SOPs).
- Clinical Studies Management:
- Create, circulate, and accurately file meeting minutes and ensure follow-up on action items.
- Process incoming adverse event reports from PMCF or studies.
- Assist in preparing clinical trial documentation, including Investigator Site File (ISF) preparation and shipping.
- Process data requests from internal personnel and external parties.
- Project and Regulatory Support:
- Lead team meetings on specific projects and serve as the primary project contact.
- Aid with regulatory submissions and ensure compliance with relevant regulatory standards.
- Prepare and present internal and external presentations.
- Provide input for clinical evaluation reports (CERs).
- Continuous Improvement:
- Undertake necessary training to enhance job performance.
- Input into the design of Case Report Forms (CRFs) and participate in their development.
Qualifications & Experience
Essential:
- Administrative experience in a related field.
- Strong organizational and communication skills.
- Ability to work independently and collaboratively in a team environment.
Desirable:
- Previous experience working in a medical device company.
- Basic knowledge of Good Clinical Practice (GCP), ISO 14155, and Medical Device Regulations (MDR).
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Clinical Research Assistant employer: Terumo Aortic
Contact Detail:
Terumo Aortic Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Research Assistant
✨Tip Number 1
Familiarise yourself with the key regulations and standards mentioned in the job description, such as ICH GCP and ISO 14155. This knowledge will not only help you during interviews but also demonstrate your commitment to compliance in clinical research.
✨Tip Number 2
Network with professionals in the clinical research field, especially those who have experience in medical device companies. Attend relevant conferences or webinars to make connections and learn more about the industry, which could give you an edge in your application.
✨Tip Number 3
Prepare to discuss specific examples of your organisational skills and how you've managed administrative tasks in previous roles. Being able to articulate your experience in maintaining documentation and files will be crucial for this position.
✨Tip Number 4
Show enthusiasm for continuous improvement and training. Be ready to talk about any relevant courses or certifications you've completed, as well as your willingness to learn new skills that will enhance your performance in the role.
We think you need these skills to ace Clinical Research Assistant
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the Clinical Research Assistant position. Understand the key duties and qualifications required, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasise any administrative experience you have in clinical research or related fields. Mention specific tasks you've performed that align with the responsibilities listed in the job description.
Showcase Your Skills: Demonstrate your strong organisational and communication skills in your application. Provide examples of how you've successfully worked independently and as part of a team in previous roles.
Tailor Your Cover Letter: Craft a personalised cover letter that addresses why you're interested in the Clinical Research Assistant role at Terumo Aortic. Mention your understanding of regulatory compliance and any relevant training or knowledge you possess regarding GCP and ISO standards.
How to prepare for a job interview at Terumo Aortic
✨Know Your Regulations
Familiarise yourself with ICH GCP, ISO 14155, and Medical Device Regulations. Being able to discuss these standards confidently will show your understanding of the role and its requirements.
✨Highlight Your Administrative Skills
Prepare examples of your previous administrative experience, especially in clinical settings. Discuss how you managed documentation and maintained files, as this is crucial for the Clinical Research Assistant position.
✨Demonstrate Team Collaboration
Be ready to share experiences where you worked effectively in a team. This role requires collaboration, so showcasing your ability to work well with others will be beneficial.
✨Prepare for Scenario Questions
Think about potential scenarios you might face in the role, such as handling adverse event reports or managing project timelines. Practising your responses will help you feel more confident during the interview.
