At a Glance
- Tasks: Ensure data integrity and compliance in oncology trials while collaborating with site personnel.
- Company: Join Parexel, a leader in clinical research with a focus on innovation.
- Benefits: Competitive salary, flexible working options, and opportunities for professional growth.
- Other info: Dynamic role with opportunities to work remotely and engage in global projects.
- Why this job: Make a real difference in cancer research and work with passionate professionals.
- Qualifications: 5+ years in CRO or Pharma, oncology trial experience, and strong communication skills.
The predicted salary is between 46000 - 52000 € per year.
Parexel is seeking Senior Clinical Research Associates for UK‑based sponsor dedicated roles. Experience in oncology trials and RECIST criteria is essential, with a minimum of 5 years in CRO or Pharma trial environments.
Responsibilities
- The Senior CRA will be responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level.
- Monitoring will be conducted in line with the Study Monitoring Plan (SMP) and will be performed virtually for the majority of activities to supplement on‑site visits.
- The Senior CRA will collaborate with the Site Manager to assure protocol compliance and inspection readiness and will coordinate with institutions and investigators.
- Ensure regulatory, ICH‑GCP and protocol compliance; evaluate site performance, communicate/escalate significant issues and develop action plans.
- Verify that the process of obtaining informed consent has been adequately performed and documented for each subject.
- Protect subject confidentiality and assess factors that might affect subject safety and data integrity, such as protocol deviations, violations and pharmacovigilance issues.
- Conduct monitoring activities using both on‑site and remote methods, where allowed by country regulations.
- Perform source document review and verify that clinical data entered in the Case Report Form (CRF) is accurate and complete.
- Manage reporting of protocol deviations and appropriate follow‑up.
- Apply query resolution techniques remotely and on‑site, and drive resolution to closure within agreed timelines.
- Perform Investigational Product (IP) inventory, reconciliation, and review of storage and security.
- Verify that IP has been dispensed and administered to subjects according to the protocol and identify any risks related to blinded or randomized information.
- Apply GCP and local regulations to ensure IP is appropriately (re)labelled, imported, released and returned.
- Manage reporting of identified issues and follow up to resolution.
- Document activities via follow‑up letters, monitoring reports, communication logs and other required project documents as per SOPs, CMP and SMP.
- Ensure all activities are managed by site personnel who are appropriately delegated and trained.
- Enter data into tracking systems to monitor observations, status and action items; manage site‑level activities and communication to meet project objectives, deliverables and timelines.
- Review data entry timeliness, missing pages, outstanding queries, and database lock timelines.
- Review site signature sheet and delegation of duties log to confirm staff changes are documented and training compliance is maintained.
- Follow up on escalated adverse event monitoring (AEM) report queries.
- Check that site and external facilities, equipment, and supplies are adequate and have valid expiry dates.
- Verify that site logs are complete and up to date (e.g., Site Visit Log, Screening and Enrollment Log, Signature Sheet and Delegation of Duties Log, Subject Identification Code List, IP Accountability Log).
- Collaborate with the primary Site Manager to act as the primary liaison with site personnel.
- Prepare for and attend Investigator Meetings and sponsor face‑to‑face meetings.
- Participate in global clinical monitoring and project staff meetings, including client representation where applicable.
Qualifications
- Minimum 5 years of experience in CRO or Pharma trial environments.
- Demonstrated experience in oncology trials and familiarity with RECIST criteria.
- Ability to evaluate site performance and communicate significant issues to the project team.
- Proficiency in local language required.
- Fluency in English required.
Skills
- Networking and relationship building skills; effective communication with internal and external stakeholders.
- Adaptability to changing technologies and processes, overcoming barriers during implementation.
- Excellent verbal and written communication, presentation and interpersonal skills.
- Ability to build effective relationships with investigator site staff and other stakeholders.
Education
- Bachelor’s degree or RN in a related field, or an equivalent combination of education, training and experience.
Senior Clinical Research Associate (Oncology Experience Required) - UK - FSP in Uxbridge employer: Parexel
At Parexel, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation in the field of clinical research. Our UK-based roles provide Senior Clinical Research Associates with unique opportunities for professional growth, particularly in oncology trials, while enjoying the flexibility of virtual monitoring combined with on-site visits. With a commitment to employee development and a focus on maintaining high standards of data integrity and compliance, Parexel is dedicated to creating a rewarding and meaningful work environment for all team members.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Clinical Research Associate (Oncology Experience Required) - UK - FSP in Uxbridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who have experience in oncology trials. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Get comfy with virtual interviews! Since most monitoring will be done remotely, practice your video call skills. Make sure you’re familiar with the tech and have a quiet, professional space to chat.
✨Tip Number 3
Show off your expertise! During interviews, highlight your experience with RECIST criteria and data integrity. Use specific examples from your past roles to demonstrate how you’ve tackled challenges in clinical trials.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search!
We think you need these skills to ace Senior Clinical Research Associate (Oncology Experience Required) - UK - FSP in Uxbridge
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your oncology experience and any relevant trials you've worked on. We want to see how your background aligns with the Senior CRA role, so don’t hold back on showcasing your skills!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about clinical research and how your experience meets the job requirements. We love seeing genuine enthusiasm for the role.
Showcase Your Compliance Knowledge:Since compliance with ICH GCP and local regulations is key, make sure to mention any specific experiences you have in this area. We’re looking for candidates who can ensure data integrity and quality at the site level.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy!
How to prepare for a job interview at Parexel
✨Know Your Oncology Stuff
Make sure you brush up on your oncology trial knowledge, especially RECIST criteria. Be ready to discuss your past experiences in detail, as this will show that you’re not just familiar with the terms but have practical insights to share.
✨Demonstrate Compliance Knowledge
Familiarise yourself with ICH GCP and local regulations. Prepare examples of how you've ensured compliance in previous roles, as this will highlight your attention to detail and commitment to data integrity.
✨Showcase Your Communication Skills
Since you'll be liaising with site personnel and project teams, practice articulating your thoughts clearly. Think of scenarios where effective communication resolved issues or improved site performance, and be ready to share those stories.
✨Prepare for Virtual Monitoring Discussions
Given the emphasis on virtual monitoring, be prepared to discuss your experience with remote methods. Highlight any tools or technologies you've used and how they helped maintain data quality and compliance during trials.
