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- Tasks: Oversee clinical trial sites, ensuring compliance and effective communication.
- Company: Join a leading organisation in clinical research dedicated to advancing healthcare.
- Benefits: Enjoy flexible working options, travel opportunities, and professional development.
- Why this job: Make a real impact in healthcare while working in a dynamic team environment.
- Qualifications: Bachelor's degree in life sciences; 3+ years in clinical research required.
- Other info: Frequent travel to clinical sites is essential for this role.
The predicted salary is between 28800 - 43200 £ per year.
The Clinical Site Monitor is responsible for overseeing and managing clinical trial sites to ensure compliance with regulatory requirements, study protocols, and Good Clinical Practice (GCP). This role involves regular site visits, data verification, and communication with site personnel to ensure that clinical trials are conducted efficiently and effectively.
Qualifications
- Bachelor's degree in life science/related field, advanced degree preferred
- Minimum of 3+ years in clinical research industry
- Solid understanding of GCP guidelines, regulatory requirements (e.g., FDA, EMA), and clinical trial processes
- Previous experience as a clinical research associate/assistant, preferably in hepatology
- Excellent organizational, communication, and interpersonal skills
- Ability to manage multiple priorities and work effectively in a team environment
- Work well under pressure ensuring tasks are prioritized and goals are met
- Willingness to travel frequently to clinical trial sites
Responsibilities
- Conduct regular site visits to monitor study progress, verify adherence to study protocols, and ensure proper documentation
- Assess site performance and identify any issues or risks that may impact the integrity of the trial
- Provide training and guidance to site staff on study protocols, procedures, and regulatory requirements
- Review and verify source data against case report forms (CRFs) and other study documentation to ensure accuracy and completeness
- Identify and resolve discrepancies or issues in data collection and reporting
- Ensure that clinical trials are conducted in compliance with regulatory requirements, including FDA guidelines, ICH GCP, and local regulations
- Perform audits and inspections to assess site adherence to study protocols and GCP standards
- Address and resolve any compliance issues or non-conformances
- Serve as the primary point of contact between the sponsor and the clinical site
- Provide regular updates and reports on site performance, progress, and any issues to the study team and sponsor
- Facilitate communication and collaboration between site staff, investigators, and the study team
- Ensure that all study-related documents are accurate, complete, and up-to-date
- Maintain thorough and organized records of monitoring activities, site correspondence, and study data
- Identify potential issues or risks related to study conduct and develop strategies to address them
- Provide solutions and recommendations to enhance site performance and trial outcomes
Clinical Research Site Monitor employer: Initial Therapeutics, Inc.
Contact Detail:
Initial Therapeutics, Inc. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Research Site Monitor
✨Tip Number 1
Familiarise yourself with the latest GCP guidelines and regulatory requirements. This knowledge will not only help you in interviews but also demonstrate your commitment to maintaining high standards in clinical research.
✨Tip Number 2
Network with professionals in the clinical research field, especially those who have experience as Clinical Research Site Monitors. Attend industry conferences or webinars to make connections and learn about potential job openings.
✨Tip Number 3
Prepare for site visits by understanding the specific protocols and challenges of the sites you may be monitoring. This preparation will allow you to engage more effectively with site personnel and demonstrate your proactive approach.
✨Tip Number 4
Showcase your organisational and communication skills during any interactions with us. Being able to articulate how you manage multiple priorities and work under pressure can set you apart from other candidates.
We think you need these skills to ace Clinical Research Site Monitor
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in clinical research, particularly any roles as a clinical research associate or assistant. Emphasise your understanding of GCP guidelines and regulatory requirements.
Craft a Strong Cover Letter: In your cover letter, express your passion for clinical research and detail how your skills align with the responsibilities of the Clinical Research Site Monitor role. Mention specific experiences that demonstrate your ability to manage multiple priorities and work under pressure.
Highlight Relevant Qualifications: Clearly state your educational background, especially if you have a degree in life sciences or a related field. If you possess an advanced degree, make sure to mention it as it is preferred for this position.
Showcase Communication Skills: Since the role requires excellent communication and interpersonal skills, provide examples in your application of how you've effectively communicated with team members or site personnel in previous roles.
How to prepare for a job interview at Initial Therapeutics, Inc.
✨Know Your GCP Guidelines
Make sure you have a solid understanding of Good Clinical Practice (GCP) guidelines. Be prepared to discuss how you've applied these principles in your previous roles, especially in relation to compliance and regulatory requirements.
✨Demonstrate Your Organisational Skills
As a Clinical Research Site Monitor, you'll need excellent organisational skills. Prepare examples of how you've managed multiple priorities in the past, particularly under pressure, to show that you can handle the demands of the role.
✨Showcase Your Communication Skills
Effective communication is key in this role. Think of instances where you've successfully collaborated with site personnel or resolved conflicts. Highlight your ability to train and guide others on study protocols and procedures.
✨Be Ready to Discuss Travel Experience
Since the job requires frequent travel to clinical trial sites, be prepared to talk about your experience with travel for work. Share how you manage your time and responsibilities while on the road to reassure them of your adaptability.
