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- Tasks: Conduct on-site and remote monitoring to ensure compliance and data integrity in clinical trials.
- Company: Join a dynamic team focused on advancing clinical research and patient safety.
- Benefits: Enjoy flexible working hours, travel opportunities, and the chance to make a real impact.
- Why this job: Be part of a vital role that safeguards patient safety and enhances clinical trial quality.
- Qualifications: Experience as a CRA with knowledge of GCP and clinical trial regulations is essential.
- Other info: This role is part-time and offers regional travel within the UK and EU.
Overview
We are seeking an experienced Clinical Research Associate (CRA) level consultant to provide supplemental on-site and remote oversight in addition to CRO monitoring activities. This role will act as an extension of the sponsor’s team, ensuring compliance with protocol, Good Clinical Practice (GCP), and applicable regulatory requirements.
The position will focus on targeted, high-value oversight activities at clinical sites to safeguard data integrity, patient safety, and study compliance.
Key Responsibilities
- Perform targeted on-site visits to verify protocol adherence, data accuracy, and correct handling of biological samples, with emphasis on high-risk procedures and critical endpoints.
- Observe study conduct and review source documentation to confirm appropriate sample processing and chain-of-custody.
- Escalate potential compliance or data quality risks to the sponsor in real time.
- Act as a liaison between site staff, the sponsor, and CRO monitors to facilitate timely issue resolution.
- Apply lessons learned from prior studies to proactively identify and mitigate operational risks.
- Document all oversight activities in accordance with sponsor quality management procedures.
- Contribute to ongoing risk assessments throughout the course of the study.
Preliminary Study Details
- Enrollment: 3 to 5 patients per site
Requirements
- Proven experience as a CRA, ideally with both on-site and remote monitoring exposure in the EU and UK.
- Strong working knowledge of ICH GCP, clinical trial regulations, and sponsor oversight practices.
- Excellent communication skills in English, including written, spoken, and reading comprehension.
- Ability to work independently while maintaining a high level of communication with the sponsor team.
- Flexible to occasionally work US East Coast hours to align with the sponsor’s team.
- Willingness and ability to travel regionally within the UK and EU.
- Experience in colorectal or similar therapeutic areas is preferred.
- Part-time, time and materials basis.
- Travel up and down the UK
- Engagement length and hours to be agreed upon based on study needs.
Note
This role is currently in the pipelining stage. We are confident that feedback will be received in the coming weeks, enabling engagement with suitable talent promptly thereafter.
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Freelance Clinical Research Associate employer: Kelly Science, Engineering, Technology & Telecom
Contact Detail:
Kelly Science, Engineering, Technology & Telecom Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Freelance Clinical Research Associate
✨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 upcoming opportunities.
✨Tip Number 2
Familiarise yourself with the latest regulations and guidelines related to clinical trials, particularly ICH GCP. This knowledge will not only boost your confidence but also demonstrate your commitment to compliance during interviews.
✨Tip Number 3
Prepare to discuss specific examples from your past experiences where you successfully identified and mitigated risks in clinical trials. Highlighting these instances can set you apart from other candidates.
✨Tip Number 4
Be ready to showcase your communication skills, as this role requires liaising between various stakeholders. Practise articulating complex information clearly and concisely, which is crucial for effective collaboration.
We think you need these skills to ace Freelance Clinical Research Associate
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience as a Clinical Research Associate. Focus on your monitoring exposure, knowledge of GCP, and any specific therapeutic areas you've worked in, such as colorectal.
Craft a Compelling Cover Letter: Write a cover letter that addresses the key responsibilities outlined in the job description. Emphasise your ability to perform targeted oversight activities and your experience with compliance and data integrity.
Showcase Communication Skills: Since excellent communication skills are crucial for this role, provide examples in your application of how you've effectively communicated with site staff, sponsors, and CRO monitors in previous positions.
Highlight Flexibility and Travel Willingness: Mention your flexibility to work US East Coast hours and your willingness to travel regionally within the UK and EU. This shows you are adaptable and ready to meet the job's demands.
How to prepare for a job interview at Kelly Science, Engineering, Technology & Telecom
✨Showcase Your Experience
Be prepared to discuss your previous roles as a Clinical Research Associate, especially any experience with both on-site and remote monitoring. Highlight specific projects where you ensured compliance with protocols and GCP.
✨Demonstrate Communication Skills
Since excellent communication is key for this role, practice articulating your thoughts clearly. Be ready to provide examples of how you've effectively liaised between site staff, sponsors, and CRO monitors in past experiences.
✨Understand Regulatory Requirements
Brush up on ICH GCP and clinical trial regulations before the interview. Being able to discuss these topics confidently will show that you are well-prepared and knowledgeable about the industry standards.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving skills, particularly in high-risk situations. Think of scenarios where you had to escalate compliance issues or mitigate operational risks, and be ready to explain your thought process.