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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 certification; experience in clinical monitoring preferred.
The predicted salary is between 35000 - 45000 £ 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 in Letchworth Garden City employer: Evestia Clinical
Contact Detail:
Evestia Clinical Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Research Associate II in Letchworth Garden City
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field and let them know you're on the lookout for opportunities. You never know who might have a lead or be able to refer you directly to a hiring manager.
✨Tip Number 2
Prepare for interviews by researching the company and its recent projects. Show that you’re genuinely interested in their work and how you can contribute to their success. Tailor your responses to highlight your relevant experience and skills.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to get comfortable with common questions. This will help you articulate your thoughts clearly and confidently when it’s your turn in the hot seat.
✨Tip Number 4
Don’t forget to follow up after interviews! A quick thank-you email can go a long way in leaving a positive impression. It shows your enthusiasm for the role and keeps you fresh in their minds as they make their decision.
We think you need these skills to ace Clinical Research Associate II in Letchworth Garden City
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, especially your understanding of GCP and clinical trials.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're the perfect fit for this role. Share specific examples of your past experiences in clinical monitoring and site management that demonstrate your ability to excel in this position.
Showcase Your Soft Skills: We value collaboration and communication, so don’t forget to showcase your soft skills in your application. Mention how you've built positive relationships with sites or teams in previous roles.
Apply Through Our Website: For the best chance of success, make sure to apply through our website. This way, your application goes directly to us, and we can review it promptly!
How to prepare for a job interview at Evestia Clinical
✨Know Your GCP Inside Out
Make sure you brush up on the Principles of Good Clinical Practice (GCP) before your interview. Be ready to discuss how you've applied these principles in your previous roles, as this will show your understanding and commitment to high-quality clinical trials.
✨Showcase Your Site Management Skills
Prepare examples of how you've successfully managed investigational sites in the past. Highlight your experience with site qualification visits, regulatory submissions, and how you've built positive relationships with site staff. This will demonstrate your ability to take ownership of day-to-day activities.
✨Be Ready for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills. Think about potential protocol deviations or safety events you might encounter and how you would handle them. This will showcase your critical thinking and ability to ensure compliance.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's approach to clinical trials and their commitment to participant safety. This not only shows your interest in the role but also helps you gauge if the company aligns with your values and career goals.