At a Glance
- Tasks: Oversee clinical trial sites, ensuring compliance and conducting site visits.
- Company: Join a fully remote company leading in clinical research across the EU.
- Benefits: Enjoy flexible remote work, competitive salary, and opportunities for professional growth.
- Other info: Opportunity to travel across the UK and EU while working in a dynamic environment.
- Why this job: Be part of impactful clinical trials that enhance patient safety and data integrity.
- Qualifications: 4+ years CRA experience, preferably in oncology, with strong organisational skills.
The predicted salary is between 36000 - 60000 € per year.
Title: Senior Clinical Research Associate
Full time perm position
Location: UK based fully remote company
General Description:
The Senior CRA is a critical core team member responsible for the oversight of a defined set of clinical trial sites within the EU. They oversee clinical trial sites to ensure compliance with the Monitoring Plan, protocol, Good Clinical Practice (GCP), and local regulations. They serve as the primary point of contact for the site and act as the primary liaison between the site and my client. The CRA will conduct site visits, oversee essential document collection and review, and prepare trip reports to summarize monitoring activities.
Essential Functions of the job:
- Performs site qualification, site initiation, monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH GCP, protocol, and company SOP compliance. (Travel across UK and EU)
- Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions
- Identifies potential factors which might affect subject safety and clinical data integrity, immediately communicates/escalates serious issues to the project team and develops action plans.
- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- Verifies site processes to obtain informed consent have been adequately performed and documents for each subject
- Assess site processes, conducts source document review, and verifies site compliance with data entry requirements according to the Monitoring Plan
- Performs Source Data Review/Source Data Verification for assigned clinical trial sites
- Reviews investigational product inventory, reconciliation and storage at trial sites, ensure GCP guidelines are followed
- Reviews the Investigator Site File for accuracy and completeness
- Provides site and regional metrics into trackers to support project-level report generation
- Understands project scope, budgets, and timelines for own activities in the clinical operations team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.
- Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
- Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.
- Provides guidance at the site level towards audit readiness standards and supports preparation for audit and required follow-up actions.
Qualifications:
- Minimum of 4 years of Clinical Monitor/CRA experience in a biotech, pharmaceutical, or CRO capacity
- B.S., scientific or healthcare degree preferred
- Minimum of 3 years experience in Oncology
- Experience monitoring across the EU (at least 3 EU countries)
- Strong understanding of clinical trial processes and regulatory requirements, including ICH GCP guidelines.
- Demonstrated ability in report writing and strong ability to critically understand clinical research documents
- Excellent organizational and communication skills.
- Ability to work collaboratively in a fast-paced, dynamic environment.
- Demonstrated ability to manage multiple tasks simultaneously and to adapt to changing priorities to meet deadlines
Computer/Technology Skills: Proficient with Microsoft Office Suite, Project Management tools. Understanding of clinical trial systems, including EDC, IRT, CTMS, and TMF platforms, is a plus.
Senior Clinical Research Associate in Newport employer: Hlx Life Sciences
As a fully remote company based in the UK, we pride ourselves on fostering a supportive and flexible work culture that empowers our employees to thrive. Our Senior Clinical Research Associates benefit from comprehensive training and development opportunities, ensuring they stay at the forefront of clinical research while enjoying the work-life balance that remote work provides. Join us to be part of a dynamic team dedicated to advancing healthcare through innovative clinical trials.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Clinical Research Associate in Newport
✨Tip Number 1
Network with professionals in the clinical research field, especially those who have experience as a CRA. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends in clinical trials.
✨Tip Number 2
Familiarise yourself with the specific regulations and guidelines relevant to the countries you will be monitoring in the EU. This knowledge will not only help you during interviews but also demonstrate your commitment to compliance and safety.
✨Tip Number 3
Prepare for potential interview questions by reviewing common scenarios that a Senior CRA might face, such as handling site compliance issues or managing multiple sites. Practising your responses can help you articulate your experience effectively.
✨Tip Number 4
Showcase your understanding of the latest technologies used in clinical trials, such as EDC and CTMS platforms. Being knowledgeable about these tools can set you apart from other candidates and highlight your readiness for the role.
We think you need these skills to ace Senior Clinical Research Associate in Newport
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights relevant experience in clinical monitoring, particularly in oncology and across multiple EU countries. Emphasise your understanding of ICH GCP guidelines and any specific achievements in previous roles.
Craft a Strong Cover Letter:Write a cover letter that clearly outlines your motivation for applying to the Senior Clinical Research Associate position. Mention your experience with site management and compliance, and how you can contribute to the company's goals.
Highlight Relevant Skills:In your application, focus on your organisational and communication skills. Provide examples of how you've successfully managed multiple tasks and adapted to changing priorities in previous roles.
Proofread Your Application:Before submitting, carefully proofread your CV and cover letter for any errors or inconsistencies. A polished application reflects your attention to detail, which is crucial in clinical research.
How to prepare for a job interview at Hlx Life Sciences
✨Know Your Clinical Trial Regulations
Make sure you have a solid understanding of ICH GCP guidelines and local regulations. Be prepared to discuss how you've applied these in your previous roles, as this will demonstrate your expertise and readiness for the Senior CRA position.
✨Showcase Your Experience
Highlight your experience in monitoring clinical trials, especially in Oncology and across multiple EU countries. Use specific examples to illustrate your ability to manage site compliance and ensure data integrity.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills. Think about past challenges you've faced in site management and how you resolved them, particularly regarding subject safety and compliance issues.
✨Demonstrate Strong Communication Skills
As a Senior CRA, you'll need to liaise effectively with various stakeholders. Practice articulating your thoughts clearly and concisely, and be ready to discuss how you've successfully communicated complex information to site staff and project teams.
