At a Glance
- Tasks: Monitor clinical study sites and ensure compliance with protocols and regulations.
- Company: Leading clinical research organisation in Belfast with a commitment to innovation.
- Benefits: Competitive salary, travel opportunities, and professional development in a dynamic field.
- Other info: Flexible working environment with opportunities for career advancement.
- Why this job: Join a team making a real difference in medical device research and patient care.
- 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 & Submission process knowledge
- Knowledge of local Adverse and Serious Adverse Events reporting processes for medical device clinical studies
- Presenting and understanding Investigator and Site responsibilities
- Clear understanding of Informed Consent process and ongoing IC SDV
- Able to work flexibly as required to ensure business needs are met
- Valid Passport
Desirable Criteria:
- Current ICH GCP certification
- Previous oncology experience
- Site pre-qualification experience
- GCP and GLP Auditing
- US FDA BIMO inspection readiness preparation
- IVD and CDx Experience
We are an equal opportunity employer; applications are welcome from all and appointment will be made on the basis of merit.
Clinical Research Associate employer: ARC Regulatory Ltd
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 learning is reflected in our comprehensive training programmes and opportunities for career progression, ensuring that you can grow your expertise in a thriving environment. With a focus on innovation and compliance, we offer a unique chance to make a meaningful impact in the field of clinical research.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Research Associate
✨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 researching the company and understanding their clinical trials. Be ready to discuss how your experience aligns with their needs, especially in monitoring medical device studies. Show them you’re not just another candidate!
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a quick thank-you email to express your appreciation and reiterate your interest in the role. It keeps you fresh in their minds and shows your enthusiasm.
✨Tip Number 4
Apply through our website for the best chance at landing that Clinical Research Associate position. We love seeing applications directly from our site, and it helps us keep track of all the amazing talent out there!
We think you need these skills to ace Clinical Research Associate
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Clinical Research Associate role. Highlight your relevant experience in clinical trials, especially with medical devices, and showcase your understanding of ICH GCP and local regulations.
Craft a Compelling Cover Letter:Your cover letter should tell us why you're the perfect fit for this role. Share specific examples from your past experiences that demonstrate your skills in site monitoring and data verification.
Showcase Your Training Experience:Since training is a key part of the job, mention any experience you have in presenting study protocols or training teams. This will show us that you can effectively communicate complex information.
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any important updates!
How to prepare for a job interview at ARC Regulatory Ltd
✨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. Familiarise yourself with the ICH guidelines and be ready to discuss how you've applied these in your previous roles.
✨Showcase Your Experience
Prepare to talk about your past experiences in clinical site monitoring, especially any pivotal medical device studies you've worked on. Use specific examples to highlight your skills in data verification and protocol deviation resolution.
✨Be Ready for Scenario Questions
Expect questions that put you in hypothetical situations related to site monitoring or regulatory compliance. Think through how you would handle issues like data discrepancies or site personnel availability, and be ready to articulate your thought process.
✨Ask Insightful Questions
At the end of the interview, don’t shy away from asking questions about the company’s approach to clinical trials or their expectations for the role. This shows your genuine interest and helps you gauge if the company is the right fit for you.
