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- Tasks: Support clinical trial activities and ensure compliance with regulations and guidelines.
- Company: Emerald Clinical Trials is a global leader in advancing clinical research for better health outcomes.
- Benefits: Enjoy competitive pay, flexible working options, and career growth opportunities.
- Why this job: Make a real impact on global health while working in a collaborative and innovative environment.
- Qualifications: College diploma or degree, or 2 years of relevant experience; medical terminology knowledge preferred.
- Other info: Join a passionate team dedicated to improving lives through clinical trials.
The predicted salary is between 30000 - 42000 £ per year.
At Emerald Clinical Trials, we are a global, full-service Contract Research Organization (CRO) with a rich heritage in the Asia-Pacific region. We are dedicated to advancing clinical research through scientific expertise and operational excellence, supporting biopharmaceutical, medical device, and diagnostic customers across all trial phases, from registration to post-marketing.
Our therapeutic expertise spans renal, cardiometabolic, and oncology—areas where we make a significant impact on improving global health. At the heart of our success is our ability to combine global reach with local knowledge. Our on-the-ground teams work closely with local communities, building trust and ensuring diverse, representative patient recruitment. By prioritising people, we deliver better engagement, more accurate data, and faster results—bringing therapies to patients in need.
At our core, Emerald Clinical Trials is committed to transforming clinical research by putting people first—both patients and our employees. By joining our team, you’ll be part of a global network of passionate professionals working together to deliver better research and outcomes for millions worldwide.
Here’s What Makes Us Stand Out
- Purpose-Driven Work: You’ll contribute to clinical trials that genuinely improve lives, with a focus on therapies in renal, cardiometabolic, and oncology.
- Global Reach, Local Expertise: Our teams connect with local communities, building trust and meaningful engagement for every trial.
- Collaboration and Innovation: Work in a culture that values diverse perspectives and creative solutions to solve global health challenges.
About The Role
The Clinical Trial Specialist (CTS) is a member of the Clinical Operations team responsible for supporting clinical trial activities as the in-house site start-up and maintenance specialist. As part of the clinical trial project team, the CTS is responsible for ensuring clinical trials are conducted according to Federal Regulations, ICH guidelines, appropriate project plans, IRB/Ethic Committee requirements, and applicable SOPs and guidelines. The CTS works closely with the project team to help manage clinical trial feasibility processes, coordinate clinical trial start-up activities including collection of essential documents for site initiation/startup, submissions to central IRBs/Ethic Committees, supporting site staff in the submission to local IRBs/Ethic Committees and changes to Informed Consent Forms (ICFs).
Your Responsibilities
- Increase proficiency in Trial Master File (TMF) set-up and maintenance (filing), both hard copy and electronic as assigned by project.
- Increase proficiency in uploading and maintaining TMF files and folders in George Clinical’s file-sharing system by project as assigned.
- Serve as second reviewer for TMF QC.
- May function in the TMF Lead Role and assume responsibility for TMF setup, maintenance and oversight.
- Assist with/complete end of study TMF filing (including site close out documents), QC and archival.
- Further develop skills in preparing and participating in audit responses.
- Perform QC of work (documents, emails etc.) prior to sending out to ensure quality product deliverables.
- Further develop skills and knowledge of data entry and maintaining files/folders for Clinical Trial Management System by project as assigned.
- Further develop skills and knowledge of assisting with data entry support, tracking and submission for investigator payments by project as assigned.
- Works with CRA/CTM/PM during site start-up for feasibility, serving as point of contact for sites where applicable.
- Assist with presenting final feasibility results to PM team and/or Sponsor.
- Assists the sites in preparation, planning, organizing and collecting essential document packets (EDPs).
- Submit final EDPs to sponsor or CTM/PM as required.
About You
College / University diploma / degree; OR at least 2 years related experiences and / or training; OR equivalent combination of education and experience. Ability to perform general administrative duties as needed or required. Exposure to medical terminology preferred. Knowledge of ICH/GCP, ethical and regulatory requirements preferred.
What We Offer
We understand that great work happens when people feel valued and supported. That’s why we provide:
- Competitive Compensation: A tailored salary and benefits package to reflect your skills and experience.
- Flexibility: Enjoy hybrid or remote working arrangements, depending on your location and role.
- Career Growth: Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role.
- Employee Wellbeing: Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events.
- Global Opportunities: Be part of a company with international reach, offering you exposure to diverse projects and clients.
Interested? Apply now and help us achieve our mission to improve the health of millions worldwide.
Clinical Trial Specialist employer: Emerald Clinical
Contact Detail:
Emerald Clinical Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Trial Specialist
✨Tip Number 1
Familiarise yourself with the specific regulations and guidelines related to clinical trials, such as ICH and GCP. This knowledge will not only help you in interviews but also demonstrate your commitment to compliance and quality in clinical research.
✨Tip Number 2
Network with professionals in the clinical research field, especially those who have experience with CROs. Attend industry events or join relevant online forums to connect with potential colleagues and learn more about the role and company culture.
✨Tip Number 3
Gain hands-on experience with Trial Master File (TMF) management, as this is a key responsibility for the Clinical Trial Specialist role. Consider volunteering or seeking internships that allow you to work with TMF systems to enhance your practical skills.
✨Tip Number 4
Prepare to discuss your understanding of patient recruitment strategies during the interview. Highlight any relevant experiences you have had in engaging with local communities or working on projects that required building trust with participants.
We think you need these skills to ace Clinical Trial Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Clinical Trial Specialist. Familiarise yourself with the key tasks mentioned in the job description, such as TMF management and compliance with regulations.
Tailor Your CV: Customise your CV to highlight relevant experience and skills that align with the requirements of the Clinical Trial Specialist position. Emphasise any previous roles in clinical research or related fields, and include specific examples of your contributions.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for clinical research and your understanding of the company's mission. Mention how your background and skills can contribute to their goals, particularly in areas like patient engagement and data accuracy.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. A polished application reflects attention to detail, which is crucial in the clinical trial field.
How to prepare for a job interview at Emerald Clinical
✨Understand the Role
Before your interview, make sure you thoroughly understand the responsibilities of a Clinical Trial Specialist. Familiarise yourself with the key tasks such as TMF management, regulatory compliance, and site start-up processes. This will help you answer questions confidently and demonstrate your knowledge.
✨Showcase Relevant Experience
Be prepared to discuss your previous experiences that relate to clinical trials, even if they are not directly in the field. Highlight any administrative roles, exposure to medical terminology, or experience with ICH/GCP guidelines. Use specific examples to illustrate your skills and how they apply to the role.
✨Ask Insightful Questions
Prepare thoughtful questions to ask your interviewers about the company culture, team dynamics, and ongoing projects. This shows your genuine interest in the role and helps you assess if the company aligns with your values, especially their commitment to putting people first.
✨Demonstrate Team Collaboration Skills
Since the role involves working closely with various teams, be ready to discuss your teamwork experiences. Share examples of how you've successfully collaborated with others in past roles, particularly in high-pressure situations, to highlight your ability to contribute positively to the team environment.
