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 31500 - 38500 £ 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 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 in Lisburn employer: ARC Regulatory Ltd
ARC Regulatory is an exceptional employer for Pathologists, offering a flexible remote working environment across the UK and ROI, with occasional on-site attendance in Belfast. Our commitment to employee growth is reflected in our support for Continuing Professional Development, while our collaborative work culture fosters innovation in precision medicine and diagnostic services. Join us to be part of a team that values quality, compliance, and meaningful contributions to global clinical trials.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Research Associate in Lisburn
✨Get Involved with Local Health Initiatives
Join local community health events or volunteer for organisations like public health agencies. This not only builds your experience but also helps you network with industry professionals who might know of openings at places like ARC Regulatory Ltd.
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Check out associations like the Institute of Healthcare Management. They often have job boards, networking events, and conferences that are perfect for connecting with potential employers in health sciences administration.
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Follow health policy news and trends—being knowledgeable about the current landscape will not only help you in interviews but also make you stand out as a candidate. You can discuss recent developments and their implications when chatting with folks at ARC Regulatory Ltd.
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We think you need these skills to ace Clinical Research Associate in Lisburn
Some tips for your application 🫡
Highlight Your Relevant Experience:When applying for a role in health sciences administration, it's super important to spotlight any relevant experience you have in healthcare settings. Whether you've worked in a hospital, a clinic, or any related environment, make sure to detail those roles in your CV – focusing on your responsibilities and achievements that align with the job at ARC Regulatory Ltd.
Showcase Your Administrative Skills:Administrative skills are key in this field, so don’t hold back! Make sure your CV reflects your proficiency in things like scheduling, data management, and compliance with health regulations. Mention specific software you’ve used, such as patient management systems, as this will demonstrate your hands-on abilities and readiness for the role at ARC Regulatory Ltd.
Craft a Meaningful Cover Letter:Your cover letter should reflect your passion for the health sciences field and your eagerness to contribute to ARC Regulatory Ltd. Share a bit about why you’re drawn to this sector, any impactful situations or challenges you’ve encountered, and how they’ve shaped your desire to work in health sciences administration. This personal touch can really set you apart!
Tailor Your Documents to the Job:Don't use a one-size-fits-all approach! Make sure your CV and cover letter are specifically tailored for this role. Highlight any certifications you have relevant to health administration, and ensure you clearly connect your previous roles to the skills needed for the full-time position at ARC Regulatory Ltd. This way, you're showing them you’ve done your homework and are genuinely interested in being a part of their team.
How to prepare for a job interview at ARC Regulatory Ltd
✨Showcase Your Administrative Skills
In health sciences administration, being organised is key. Make sure you can demonstrate your skills in managing schedules, paperwork, and data accurately. Be ready to discuss specific tools you've used, like electronic health record systems or scheduling software, and how they improved efficiency in your past experiences.
✨Know Your Regulations
Familiarity with healthcare regulations and compliance is crucial. Brush up on HIPAA, GDPR, or other relevant policies before your interview. We recommend preparing examples of how you've ensured compliance or handled sensitive information in past roles—this will show you're not just knowledgeable but also responsible.
✨Prepare for Scenario Questions
Interviews for administrative roles often involve scenario-based questions to assess your problem-solving skills. Practice responses to common situations you might face, such as dealing with a challenging patient or managing a sudden schedule change. This will not only demonstrate your ability to think on your feet but also highlight your interpersonal skills.
✨Align Your Goals with the Organisation
As a full-time candidate, employers will want to know how your long-term career goals align with their mission. Take some time to research ARC Regulatory Ltd’s values and be ready to tie your passion for health sciences administration into their objectives. Demonstrating enthusiasm and career alignment can be a game-changer in this competitive field!
