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- Tasks: Support clinical trials by managing sites and ensuring compliance with protocols.
- Company: Evestia Clinical, a diverse and inclusive workplace committed to innovation.
- Benefits: 25 days vacation, health insurance, flexible work, and personal development allowance.
- Other info: Join a dynamic team with opportunities for growth and a commitment to diversity.
- Why this job: Make a real impact in clinical research while building valuable relationships.
- Qualifications: Bachelor's in life sciences or nursing, plus relevant experience in clinical monitoring.
The predicted salary is between 30000 - 40000 £ per year.
You will play a key role in supporting the successful delivery of clinical trials, taking ownership of day‑to‑day clinical monitoring and site management activities. Acting as the main point of contact for assigned investigational sites, you’ll build positive, collaborative relationships and support sites to run studies in line with the approved protocol, ICH‑GCP, applicable regulations and SOPs, helping to protect participant safety and ensure high‑quality data. You will work closely with project teams to deliver studies on time, to high quality and within budget, while supporting sites to remain audit and inspection ready at all times.
What will your job look like?
- Assists in conducting investigational site identification, feasibility and selection.
- Performs Site Qualification Visit (SQV), delivers the visit report and supports with any follow up questions or actions.
- Supports with site start‑up activities, including preparation, submission and management of regulatory and ethics applications and site clinical trial agreement and budget negotiation.
- Completes and documents in the applicable learning management system all required study‑specific training and prepares site initiation training.
- Initiates investigational sites according to the relevant procedures defined in the monitoring plan and other applicable study plans, to ensure compliance with the protocol and regulatory and ICH GCP obligations.
- Conducts monitoring tasks onsite and/or remote in accordance with the approved monitoring plan.
- Ensures that all required study documentation and records are collected and filed in the Investigator Site File and in the TMF, according to ICH‑GCP and applicable regulations.
- Conducts on‑site file reviews as per project specifications.
- Ensures site identify, document and report safety events according to the protocol, study plans, ICH‑GCP and applicable regulations.
- Identifies protocol deviations and site process failures and implements corrective and preventive actions as required to bring the site into compliance.
- Escalates observed deficiencies and issues to the clinical and/or project lead and follows all issues through to resolution.
- Provides regular progress updates on study progress to the study clinical and/or project lead, as required.
- Supports with site payments.
- Reviews and approves site visit reports.
- Performs trial close‑out visit and retrieval and/destruction of trial materials.
- Performs a final check of the Investigator Site File and TMF to ensure all required documentation is filed.
- Performs final drug reconciliation and return or destruction, as per study and site requirements.
What will you need to succeed?
- Bachelor's degree in a life science related field or a registered nursing certification or equivalent and relevant formal academic / vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 year as a clinical research monitor).
- Understanding of the Principles of Good Clinical Practice (GCP) and clinical trials regulation and able to demonstrate practical application.
- In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient to meet the requirements of the role.
What we offer you in return?
- 25 days of vacation
- Vacation days purchasing scheme
- 1 extra vacation day per each 3 years of service
- Discretionary Annual Bonus
- Sabbatical of 3 to 6 months (after 3 years of service)
- 1 volunteer day per year
- Free food and beverages at all offices
- Life Insurance
- Health Insurance and Employee Assistance Programme
- Network Groups
- Flexible and hybrid work
- Training and Personal Development Allowance
Our Commitment to Inclusion and Diversity
We actively seek and hire individuals with diverse backgrounds, voices, beliefs and perspectives. We celebrate each individual’s uniqueness and believe that diverse viewpoints fuel innovation and drive excellence. Our managers uphold an inclusive environment in hiring, promotion, training and benefits.
Equal Opportunity & Accessibility
Evestia Clinical is an equal opportunity employer committed to diversity in the workplace. We ensure fair treatment of all applicants and employees, without discrimination based on actual or perceived race, color, creed, religion, national origin, age, sex, gender identity or expression, sexual orientation, disability, veteran status or any other characteristic protected by applicable law. We are committed to providing accessibility accommodations to applicants with physical and/or mental disabilities. If you require an accommodation or special assistance during the application process, please notify our recruitment team by sending an email with your request to HR@evestiaclinical.com.
Clinical Research Associate II (CRA II) - Midlands in Letchworth employer: Evestia Clinical
Contact Detail:
Evestia Clinical Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Research Associate II (CRA II) - Midlands in Letchworth
✨Tip Number 1
Network like a pro! Reach out to professionals in the clinical research field on LinkedIn or at industry events. Building relationships can lead to job opportunities that aren’t even advertised.
✨Tip Number 2
Prepare for interviews by practising common questions and scenarios related to clinical trials. We recommend role-playing with a friend or using mock interview platforms to boost your confidence.
✨Tip Number 3
Showcase your skills during interviews by sharing specific examples from your past experiences. Highlight how you’ve successfully managed sites or ensured compliance with protocols, as this will resonate with hiring managers.
✨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 genuinely interested in joining our team.
We think you need these skills to ace Clinical Research Associate II (CRA II) - Midlands in Letchworth
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Clinical Research Associate II role. Highlight relevant experience and skills that match the job description, like your understanding of GCP and clinical trials.
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 background makes you a great fit for the team at StudySmarter.
Showcase Your Soft Skills: Don’t forget to mention your soft skills! Building positive relationships with sites is key, so highlight your communication and collaboration abilities in your application.
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It’s super easy and ensures your application goes directly to us!
How to prepare for a job interview at Evestia Clinical
✨Know Your GCP Inside Out
As a Clinical Research Associate II, you'll need to demonstrate a solid understanding of Good Clinical Practice (GCP). Brush up on the principles and be ready to discuss how you've applied them in previous roles. This shows you're not just familiar with the theory but can put it into practice.
✨Showcase Your Monitoring Experience
Be prepared to talk about your previous experience in clinical monitoring. Highlight specific examples where you successfully managed site activities or resolved issues. This will help the interviewers see that you have the hands-on experience needed for the role.
✨Build Rapport with Your Interviewers
Since building positive relationships is key in this role, use the interview to showcase your interpersonal skills. Engage with your interviewers, ask questions, and show genuine interest in their experiences. This will help you stand out as a collaborative team player.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills. Think of situations where you identified protocol deviations or implemented corrective actions. Prepare concise stories that highlight your critical thinking and ability to handle challenges effectively.