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- Tasks: Join us as a Clinical Research Associate, monitoring trials and ensuring quality in cancer research.
- Company: BeOne is a rapidly growing company dedicated to fighting cancer through innovative clinical trials.
- Benefits: Enjoy flexible work options, competitive pay, and opportunities for professional growth.
- Why this job: Make a real impact in oncology while collaborating with passionate professionals in a supportive environment.
- Qualifications: 2-5 years of CRA experience preferred; strong communication and organisational skills are essential.
- Other info: Travel up to 60% required; must be fluent in English.
The predicted salary is between 36000 - 60000 £ per year.
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BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
- The CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs.
- May be assigned to CRA activities or start-up activities, depending on experience and project needs
- Performs monitoring activities related to selection, initiation, conduct (recruitment, quality data collection) and timely completion of oncology/hematology clinical trials within the assigned region.
- Identify gaps and areas for improvement and propose CAPA.
- Supports start-up and provides local expertise.
- The CRA is responsible for collaborating closely with the Regional Clinical Operations Manager to ensure study timelines are adhered to and required quality standards are maintained.
CRA activities
- Perform feasibility, site identification, selection and evaluation, preparing/supporting initial list of sites and recruitment targets
- Provides protocol and related study training to assigned sites.
- Conducts monitoring (pre-study, initiation, routine monitoring and closeout) visit per monitoring plan and applicable SOPs
- Completes monitoring visit reports in accordance with ICH-GCP, BeiGene standards and SOP
- Manages sites and site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
- Establish regular lines of communication with sites and reports site progress, issues and proposed action to Clinical Operations
- Ensure inspection readiness of the study and sites
- Collaborates with Regional Clinical Operations Manager and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)
- Attends disease indication project specific training and general CRA training as required
- Facilitate Study Oversight Visits (SOVs), site audits and/or inspections, as required
- Evaluates the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate.
- Anticipate and identify site issues; propose corrective and preventative actions; identify gaps and utilize opportunities. Constantly strive for operating excellence, question status-quo and promote innovation.
Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook Other
Qualifications:
- Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
- Ideally 2-5 years of (CRA) monitoring experience in the pharmaceutical or CRO industry • Excellent communication and interpersonal skills
- Excellent organizational skills and ability to prioritize and multi-task
- Fluent in English (writing and speaking)
Travel: up to 60%
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
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Clinical Research Associate employer: BeiGene
Contact Detail:
BeiGene Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Research Associate
✨Tip Number 1
Familiarise yourself with ICH guidelines and GCP regulations, as these are crucial for a Clinical Research Associate role. Understanding these standards will not only help you in interviews but also demonstrate your commitment to quality in clinical trials.
✨Tip Number 2
Network with professionals in the clinical research field, especially those who have experience in oncology or hematology. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in clinical trials.
✨Tip Number 3
Showcase your organisational skills by discussing any relevant projects where you successfully managed multiple tasks or deadlines. This is particularly important for a CRA, as you'll need to juggle various responsibilities across different sites.
✨Tip Number 4
Prepare to discuss specific examples of how you've identified gaps in processes and proposed solutions in previous roles. This aligns with the expectations of the CRA position, where continuous improvement is key to success.
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, particularly any monitoring activities you've undertaken. Emphasise your understanding of ICH guidelines and GCP, as well as your ability to manage site performance.
Craft a Strong Cover Letter: In your cover letter, express your passion for fighting cancer and how your background aligns with the company's mission. Mention specific experiences that demonstrate your collaborative spirit and problem-solving skills.
Showcase Relevant Skills: Highlight your proficiency in Microsoft Office tools, especially Excel and PowerPoint, as these are essential for data management and presentations. Also, mention your organisational skills and ability to multitask effectively.
Prepare for Potential Questions: Anticipate questions related to your experience with clinical trials and your approach to monitoring and site management. Be ready to discuss how you identify gaps and propose corrective actions in your previous roles.
How to prepare for a job interview at BeiGene
✨Know Your ICH and GCP Guidelines
Make sure you have a solid understanding of the International Council for Harmonisation (ICH) guidelines and Good Clinical Practice (GCP). Be prepared to discuss how these regulations apply to clinical trials, as this knowledge is crucial for a Clinical Research Associate role.
✨Demonstrate Your Monitoring Experience
Highlight your previous experience in monitoring clinical trials. Be ready to share specific examples of how you've managed site performance, tracked regulatory submissions, or resolved data queries. This will show your practical understanding of the role.
✨Showcase Your Communication Skills
As a CRA, you'll need excellent communication skills. Prepare to discuss how you've effectively communicated with clinical sites, managed relationships, and facilitated training sessions. Consider sharing a challenging situation where your communication made a difference.
✨Emphasise Your Problem-Solving Abilities
Be ready to talk about times when you've identified gaps or issues in clinical trials and proposed corrective actions. This demonstrates your proactive approach and ability to drive improvements, which is highly valued in this role.
