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- Tasks: Monitor clinical trials, ensuring data integrity and supporting investigator sites.
- Company: Join a leading global CRO dedicated to innovative pharmaceutical research.
- Benefits: Enjoy flexible working arrangements, career progression, and a supportive work environment.
- Why this job: Be part of groundbreaking research and develop your skills in a collaborative team.
- Qualifications: Bachelor’s degree in life sciences; CRA experience preferred but strong candidates considered.
- Other info: Opportunity for mentorship and professional development within a dedicated FSP role.
The predicted salary is between 30000 - 50000 £ per year.
CCS Global are working on an exclusive opportunity to join a leading global CRO who are seeking experienced and ambitious Clinical Research Associates (CRA I/II) to join a dedicated FSP team, supporting a single, prestigious pharmaceutical sponsor. This unique opportunity offers the chance to become an integral part of the sponsor's clinical development operations, gaining in-depth therapeutic knowledge and contributing directly to the progression of their clinical trials portfolio.
Role Overview: As a CRA I/II, you will be responsible for ensuring the integrity and quality of clinical data through meticulous on-site and remote monitoring activities. You will cultivate strong relationships with investigator sites, providing essential support and guidance, while adhering to ICH-GCP guidelines, sponsor SOPs, and study protocols.
Key Responsibilities:
- Conduct comprehensive monitoring visits, verifying source data against CRFs and ensuring data accuracy.
- Proactively manage site relationships, addressing queries and providing ongoing support to site personnel.
- Identify and resolve site-related issues, ensuring timely reporting of deviations and safety concerns.
- Prepare detailed monitoring visit reports and maintain accurate study documentation.
- Contribute to all stages of the clinical trial lifecycle, including site initiation, interim monitoring, and close-out.
- Ensure strict compliance with regulatory requirements and sponsor expectations.
- Participate in team meetings and training sessions.
- For CRA II, provide mentorship and training to junior CRAs, fostering their professional development.
Candidate Profile:
- Bachelor’s degree in a life science or related discipline.
- Minimum 1 year of demonstrable CRA experience (for CRA II). CRA I candidates with strong academic backgrounds will be considered for CRA I positions and 6 months of onsite monitoring as a minimum.
- Thorough understanding of ICH-GCP guidelines and relevant regulatory frameworks.
- Exceptional communication, interpersonal, and organisational skills.
- Proven ability to work autonomously and collaboratively within a team environment.
- Proficiency in Microsoft Office Suite.
- Valid driver’s license and willingness to travel as required.
- Right to work in the UK without the need for sponsorship.
Client and Opportunity Highlights:
- Exceptional Retention: This team benefits from consistently high retention rates, reflecting a supportive and positive working environment.
- Structured Progression: The client has a culture of continuous learning and development, with clear pathways for career advancement within the FSP model and the wider CRO.
- Work-Life Balance: The client prioritises employee well-being, promoting a healthy work-life balance through flexible working arrangements and supportive management.
- Dedicated FSP Role: This offers stability, project continuity and a chance to deep dive into one sponsor's portfolio, rather than work across multiple studies and sponsors.
- Exposure to Cutting-Edge Clinical Trials: You will contribute to groundbreaking research within a leading pharmaceutical sponsor's portfolio.
To Apply: Please submit your CV outlining your relevant experience and career aspirations to r.kelly@completeclinicalsolutions.com. CCS Global is committed to providing equal opportunities and ensuring a fair and transparent recruitment process.
Clinical Research Associate employer: CCS-Global
Contact Detail:
CCS-Global Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Research Associate
✨Tip Number 1
Network with professionals in the clinical research field, especially those who work as Clinical Research Associates. Attend industry conferences or local meetups to connect with potential colleagues and learn about job openings directly from them.
✨Tip Number 2
Familiarise yourself with the specific therapeutic areas that the pharmaceutical sponsor focuses on. This knowledge can help you stand out during interviews and demonstrate your genuine interest in their projects.
✨Tip Number 3
Prepare for the interview by practising common CRA interview questions and scenarios. Consider how you would handle site-related issues or ensure compliance with ICH-GCP guidelines, as these are crucial aspects of the role.
✨Tip Number 4
Showcase your organisational skills and attention to detail during any interactions with the company. Whether it's through follow-up emails or during the interview, demonstrating these traits can reinforce your suitability for the role.
We think you need these skills to ace Clinical Research Associate
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in clinical research. Emphasise any previous roles as a Clinical Research Associate, detailing your responsibilities and achievements that align with the job description.
Craft a Strong Cover Letter: Write a compelling cover letter that explains why you are interested in this specific role and how your skills and experiences make you a suitable candidate. Mention your understanding of ICH-GCP guidelines and your ability to manage site relationships.
Highlight Relevant Skills: In your application, focus on key skills such as communication, organisation, and the ability to work autonomously. Provide examples of how you've demonstrated these skills in past roles, particularly in monitoring activities.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects attention to detail, which is crucial in clinical research.
How to prepare for a job interview at CCS-Global
✨Know Your ICH-GCP Guidelines
Make sure you have a solid understanding of the ICH-GCP guidelines, as they are crucial for the role. Be prepared to discuss how you've applied these principles in your previous experiences.
✨Showcase Your Monitoring Experience
Highlight any specific monitoring visits you've conducted and the outcomes. Discuss how you ensured data accuracy and resolved site-related issues, as this will demonstrate your hands-on experience.
✨Emphasise Communication Skills
Since building relationships with investigator sites is key, be ready to share examples of how you've effectively communicated and supported site personnel in the past. Strong interpersonal skills are essential for this role.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities. Prepare for scenarios where you might need to address site issues or ensure compliance with regulatory requirements, showcasing your critical thinking skills.
