At a Glance
- Tasks: Monitor clinical study sites and ensure compliance with protocols and regulations.
- Company: Leading healthcare organisation focused on innovative medical devices.
- 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 mission-driven team making a real difference in oncology research.
- 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 (CRA) - Oncology in Belfast employer: ARC Regulatory Ltd
As a Clinical Research Associate (CRA) in Belfast, you will join a dynamic team dedicated to advancing oncology 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 field of medical device clinical studies.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Research Associate (CRA) - Oncology in Belfast
✨Get Involved in Local Health Initiatives
Dive into local health initiatives or volunteer at community health events. This not only boosts your practical experience but also gets you noticed among professionals in human medicine who may have leads on full-time positions like Clinical Research Associate (CRA) - Oncology at ARC Regulatory Ltd.
✨Connect with Professionals via Medical Associations
Join professional associations related to human medicine, such as the Royal College of Physicians. Attend their conferences and networking events to meet potential employers in a relaxed setting. Who knows, you might just bump into someone from ARC Regulatory Ltd!
✨Showcase Your Passion and Expertise Online
Build a personal website or a professional blog where you can share your insights on human medicine topics. This portfolio can catch the eye of recruiters looking for dedicated individuals for full-time roles like Clinical Research Associate (CRA) - Oncology.
✨Leverage University Career Services
If you’re still in or recently graduated from university, don’t hesitate to use your career services. They often have exclusive listings and contacts in the human medicine field that can help you land a full-time gig at places like ARC Regulatory Ltd.
We think you need these skills to ace Clinical Research Associate (CRA) - Oncology in Belfast
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for the Clinical Research Associate (CRA) - Oncology at ARC Regulatory Ltd, focus on highlighting your clinical experience and any specific training you've undergone. Include any relevant placements or internships you’ve completed, as well as any certifications that bolster your qualifications in human medicine.
Highlight Your Soft Skills:In the field of human medicine, soft skills are just as crucial as technical knowledge. Mention your communication skills, empathy, and teamwork experiences in your CV and cover letter. This shows that you can work well in a clinical setting and with patients, which is super important in this industry!
Tailor Your Cover Letter Thoughtfully:Be sure to personalise your cover letter for the Clinical Research Associate (CRA) - Oncology at ARC Regulatory Ltd. Mention why you’re passionate about human medicine and how you align with the company’s mission. This is your chance to convey your enthusiasm and make a case for why you'll be a valuable addition to the team!
Include Continuing Education:Make sure to mention any ongoing education or courses you’re taking to keep your skills sharp. In human medicine, staying updated with the latest practices is key. It shows you’re dedicated to your field, which employers like ARC Regulatory Ltd will definitely appreciate!
How to prepare for a job interview at ARC Regulatory Ltd
✨Brush Up on Clinical Knowledge
Since you're aiming for a role in human medicine, make sure you’re sharp on the latest clinical guidelines and practices relevant to the position. Be prepared to discuss case studies or scenarios you might encounter in the role. This will show that you're not just knowledgeable but also ready to apply that knowledge in real-life situations.
✨Demonstrate Soft Skills
In human medicine, technical skills are crucial, but don’t forget to showcase your soft skills like communication, empathy, and teamwork. In your answers, share specific examples of how you've worked effectively with patients or colleagues in the past, as these traits are highly valued in clinical settings.
✨Know Your CV Backwards
As you’re applying for a full-time position, your CV should tell a story. Be ready to discuss every part of it, especially your clinical experiences, the impact you had, and what you learned. Employers want to see how your journey has prepared you for this role, so think of it like you're taking them through your professional narrative.
✨Prepare for Ethical Scenarios
Ethics are a big deal in human medicine, so expect questions that assess your decision-making in tricky situations. Think about how you'd handle ethical dilemmas or patient confidentiality concerns. Prepare a few examples that illustrate your thought process and how you prioritise patient welfare in your decision-making.
