At a Glance
- Tasks: Monitor clinical study sites and ensure compliance with protocols and regulations.
- Company: Leading clinical research organisation in Belfast with a focus on innovation.
- Benefits: Competitive salary, travel opportunities, and professional development.
- Other info: Exciting career growth potential in a supportive environment.
- Why this job: Join a dynamic team and contribute to groundbreaking medical device studies.
- Qualifications: Life Sciences degree and extensive experience in clinical research monitoring.
The predicted salary is between 40000 - 50000 £ per year.
Location: Belfast / requires travel when required
Job Purpose: Act in the role of clinical site monitor to regularly visit/remotely assess in vitro diagnostic medical device clinical study sites and ensure that the study is conducted in compliance with the study protocol, ICH GCP and local regulatory requirements.
Key Responsibilities:
- The CRA will be involved in all aspects of the in vitro diagnostic clinical trial, including qualification of investigational sites as well as setting up, initiating, monitoring and close-out of assigned study sites.
- The CRA will be required to carry out the following duties at clinical investigation sites:
- Complete appropriate training sessions with Project Leads
- Identify and assess the suitability of facilities to be used as the device study/investigation site
- Conduct site monitoring in accordance with the study protocol/risk-based site monitoring plan
- Liaise with site to agree study personnel availability and visit date
- Provide written confirmation of visit date and agenda
- Prepare and review detailed study monitoring reports
- Provide detailed study data and communication trackers in a timely manner (as per protocol/monitoring plan)
- Follow up on site and sponsor actions to close out
- Present and train study protocols to research study teams
- Collect all site documents for Sponsor records
- Reconcile site regulatory binder with Sponsor Master File
- Attend Investigator Meetings
- Design and complete SDV case report forms
- Coordinate with the ethics committee on study continuation and annual reporting
- Report to ARC Regulatory Project Lead to prioritise actions
- Any other duties, within reason and capability, as determined by ARC Regulatory management
Essential Criteria:
- Life Sciences Degree or equivalent
- At least 5 years’ experience in Clinical Research with minimum 3 years’ experience monitoring general Medical Device or IVD Medical Device clinical studies
- Proven experience in all aspects of clinical study site monitoring from selection and start up to close out
- Highly experienced in source document/data verification with a forensic ability to identify relevant issues in the integrity of study data
- Significant experience in data query and protocol deviation resolution
- Knowledge of local regulations governing medical device clinical research
- Knowledge of clinical data management requirements
- Expert knowledge of Good Clinical Practice; ICH-GCP and ISO 14155
- Experience of Monitoring pivotal medical device/in vitro diagnostic medical device clinical studies
- Knowledge of monitoring Essential Study Documents
- Experience in presenting and training on study Protocol, Investigators’ Brochure and (e)Case Report Form user acceptance testing
- Writing and presenting Clinical Study Monitoring Plans
Ethics Committees applications are welcome from all and appointment will be made on the basis of merit.
Clinical Research Associate in Belfast employer: ARC Regulatory
As a Clinical Research Associate in Belfast, you will join a dynamic team dedicated to advancing medical device research while enjoying a supportive work culture that prioritises employee development and collaboration. Our commitment to continuous training and professional growth ensures that you will have ample opportunities to enhance your skills and advance your career in a thriving environment, all while contributing to meaningful projects that impact patient care.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Research Associate in Belfast
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field, attend industry events, and join relevant online groups. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ICH GCP and local regulations. Be ready to discuss your experience with monitoring medical device studies and how you've tackled challenges in past roles. Confidence is key!
✨Tip Number 3
Showcase your skills through real-life examples during interviews. Talk about specific projects where you’ve excelled in site monitoring or data verification. This will help potential employers see the value you bring to their team.
✨Tip Number 4
Don’t forget to apply through our website! We’re always on the lookout for talented Clinical Research Associates. Keep an eye on our job listings and make sure your application stands out by tailoring it to the role.
We think you need these skills to ace Clinical Research Associate in Belfast
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Clinical Research Associate role. Highlight your experience in clinical monitoring and any relevant qualifications. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about clinical research and how your skills make you a perfect fit for the role. Keep it engaging and personal – we love a good story!
Showcase Your Experience:When detailing your experience, focus on specific examples that demonstrate your expertise in monitoring clinical studies. We’re looking for evidence of your ability to handle the responsibilities outlined in the job description.
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy – just follow the prompts!
How to prepare for a job interview at ARC Regulatory
✨Know Your Stuff
Make sure you brush up on your knowledge of Good Clinical Practice (GCP) and the specific regulations governing medical device clinical research. Being able to discuss these topics confidently will show that you're not just familiar with the basics, but that you truly understand the nuances of the role.
✨Showcase Your Experience
Prepare to share specific examples from your past roles that highlight your experience in monitoring clinical studies. Think about challenges you've faced, how you resolved them, and what you learned. This will help demonstrate your problem-solving skills and your ability to handle the responsibilities of a Clinical Research Associate.
✨Ask Smart Questions
Interviews are a two-way street, so come prepared with insightful questions about the company’s clinical trials and their approach to site monitoring. This not only shows your interest in the position but also gives you a chance to assess if the company aligns with your career goals.
✨Be Ready for Scenario-Based Questions
Expect to be asked how you would handle specific situations related to site monitoring or protocol deviations. Practise articulating your thought process and decision-making skills in these scenarios, as it will showcase your critical thinking and adaptability in real-world situations.
