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 5 years of clinical research experience required.
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.
- 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 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 in Lisburn 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 growth and development. Our commitment to excellence is reflected in our comprehensive training programmes and opportunities for career progression, ensuring that you can thrive in your role while making a meaningful impact in the healthcare sector. With a focus on collaboration and innovation, we offer a unique environment where your contributions are valued and recognised.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Research Associate in Lisburn
✨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
Don’t just apply anywhere; focus on companies that align with your values and career goals. Use our website to find roles that excite you and tailor your approach to each application. Quality over quantity, folks!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in showing your enthusiasm for the role. It keeps you fresh in their minds and demonstrates your professionalism. Let’s make that impression count!
We think you need these skills to ace Clinical Research Associate in Lisburn
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 in monitoring and compliance with ICH GCP and local regulations. We want to see how your background fits with what we do!
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 align with our needs. Be sure to mention any specific experiences that relate to the responsibilities listed in the job description.
Showcase Your Skills:Don’t forget to showcase your skills in data verification and protocol deviation resolution. We love candidates who can demonstrate their forensic ability to identify issues in study data. Make it clear how you’ve tackled these challenges in the past!
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. Plus, it shows you’re keen on joining our team!
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. 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 with in vitro diagnostic medical devices. Have specific examples ready that highlight your ability to identify issues, resolve data queries, and ensure compliance with study protocols.
✨Be Ready for Scenario Questions
Expect scenario-based questions where you might need to demonstrate how you'd handle specific challenges in a clinical trial setting. Think about situations you've faced before and how you navigated them successfully.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions that show your interest in the role and the company. Inquire about their current projects, team dynamics, or how they approach training for new protocols. This shows you're engaged and serious about the position.
