At a Glance
- Tasks: Monitor clinical research studies and ensure compliance with regulations while gaining industry knowledge.
- Company: Join a leading organisation in clinical research with a focus on innovation.
- Benefits: Gain hands-on experience, competitive pay, and opportunities for professional growth.
- Other info: Dynamic team environment with opportunities to learn and develop your skills.
- Why this job: Make a difference in healthcare by supporting vital clinical trials and research.
- Qualifications: Bachelor’s degree in health-related fields and some research experience preferred.
The predicted salary is between 30000 - 40000 £ per year.
Responsible for project activities associated with monitoring functions of Phase I through Phase IV clinical research studies and Real World Evidence (RWE) studies while developing an understanding of the drug development process, International Conference on Harmonization (ICH) / Good Clinical Practice (GCP) and relevant regulations. Performs management of study site activities in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs).
What You'll Do
- Perform in-house monitoring activity related to clinical trials while adhering to all applicable regulatory and SOPs.
- Perform on-site clinical trial monitoring, co-monitoring, and close-out activities, with oversight from project CRAs when required, while adhering to all applicable regulatory requirements and SOPs.
- May conduct independent on-site monitoring as sponsor requirements allow.
- Assist project teams with study start-up activities, including site selection and phone Pre-Study Visits to identify and evaluate potential investigative sites.
- Collect, review, file, and track regulatory documents for investigative sites, when required, including assisting the project CRA with reconciliation of the TMF/eTMF.
- Participate in or conduct study specific training for CTI personnel or investigative sites.
- Attend Investigator or sponsor meetings.
- Assist in development of monitoring tools for study, including remote monitoring checklist for eCRF studies.
- Conduct routine remote monitoring of eCRF studies, issuing queries in the database.
- Compile monitoring visit packets and provide to project CRAs prior to on-site monitoring visits.
- Assist in maintaining project-related tracking for CRA visit reports and letters, protocol deviations, serious adverse events (SAEs), and IND Safety reports.
- Contact sites to ensure proper completion of monitoring/data management queries within timelines, resolution of action items related to Interim Monitoring Visits, and other site management tasks.
- Serve as support/contact for CRA Team questions.
- Assist with project-specific administrative activities as member of project team.
- Increase knowledge of drug development process, therapeutic areas, ICH/GCP, and any applicable local regulatory requirements.
What You'll Bring
- 1 year of research industry experience or equivalent experience.
- Bachelor’s degree in allied health fields such as nursing, pharmacy, or health/natural science.
- RN with Associate’s Degree Preferred.
- Previous experience conducting clinical pharmaceutical research studies at research site, pharmaceutical company, or CRO.
- Experience or education providing sound basic knowledge of medical and pharmaceutical terminology.
- Master’s Degree in allied health fields such as nursing, pharmacy, or health/natural science.
Competencies
- Excellent verbal and written communication skills.
- Excellent organizational, record retention, and time management skills.
- Excellent decision-making, customer service, and interpersonal skills.
- Ability to process visit reports and expense reports effectively.
- Ability to obtain credit cards for purpose of paying expenses while traveling.
- Ability to work independently and as part of project team.
- Proficient in use of laptop computer and software systems.
- Ability to understand basic and complex medical details.
- Understanding of basic data processing functions is preferred.
- Knowledge of ICH/GCP and all applicable local regulatory requirements is preferred.
Clinical Mon Assoc I employer: CTI Clinical Trial and Consulting Services
Join a leading organisation in clinical research where you will be empowered to grow your expertise in drug development while contributing to impactful studies. Our collaborative work culture fosters continuous learning and professional development, ensuring that you are well-equipped to excel in your role as a Clinical Monitoring Associate. Located in a vibrant area, we offer competitive benefits and a supportive environment that values your contributions and encourages innovation.
Contact Details:
CTI Clinical Trial and Consulting Services Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Mon Assoc I
✨Tip Number 1
Network like a pro! Reach out to professionals in the clinical research field on LinkedIn or at industry events. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ICH/GCP guidelines and the drug development process. We recommend practising common interview questions with a friend or even in front of the mirror to boost your confidence!
✨Tip Number 3
Showcase your skills during interviews by sharing specific examples from your past experiences. We want to hear about how you’ve handled monitoring activities or site management tasks – real-life stories make you stand out!
✨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 and eager to join our team.
We think you need these skills to ace Clinical Mon Assoc I
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights relevant experience in clinical research and any knowledge of ICH/GCP guidelines. We want to see how your background aligns with the role, so don’t be shy about 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 makes you a great fit for our team. Keep it concise but impactful!
Showcase Your Communication Skills:Since excellent communication is key in this role, make sure your application reflects your verbal and written skills. Whether it's through your CV or cover letter, clarity and professionalism are essential.
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 CTI Clinical Trial and Consulting Services
✨Know Your Stuff
Make sure you brush up on the drug development process, ICH/GCP guidelines, and relevant regulations. Familiarise yourself with the specifics of clinical trials and be ready to discuss how your experience aligns with these areas.
✨Showcase Your Experience
Prepare to talk about your previous roles in clinical research or related fields. Highlight any specific projects you've worked on, especially those involving monitoring activities or site management, as this will demonstrate your hands-on knowledge.
✨Ask Smart Questions
Come prepared with insightful questions about the company's approach to clinical trials and their expectations for the role. This shows your genuine interest and helps you gauge if the company is the right fit for you.
✨Demonstrate Team Spirit
Since this role involves working closely with project teams and CRAs, be ready to discuss how you collaborate effectively. Share examples of how you've contributed to team success in past roles, showcasing your interpersonal skills.
