At a Glance
- Tasks: Support clinical trials by managing sites and ensuring compliance with protocols.
- Company: Dynamic healthcare company committed to innovation and diversity.
- Benefits: Generous vacation, health insurance, flexible work, and personal development opportunities.
- Other info: Inclusive culture that values diverse perspectives and offers career growth.
- Why this job: Make a real difference in clinical research while building valuable skills.
- Qualifications: Bachelor's in life sciences or nursing, plus relevant experience.
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.
Clinical Research Associate II (CRA II) - Midlands employer: Evestia Clinical
As a Clinical Research Associate II in the Midlands, you will thrive in a supportive and inclusive work culture that prioritises employee growth and development. With benefits such as flexible working arrangements, generous vacation policies, and a commitment to diversity, our company fosters an environment where you can make a meaningful impact on clinical trials while enjoying a rewarding career path.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Research Associate II (CRA II) - Midlands
✨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 yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ICH-GCP and clinical trial regulations. We want you to feel confident discussing how you can ensure compliance and participant safety during trials.
✨Tip Number 3
Showcase your experience with site management and monitoring tasks. Be ready to share specific examples of how you've handled protocol deviations or site process failures in past roles.
✨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 about their job search.
We think you need these skills to ace Clinical Research Associate II (CRA II) - Midlands
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Clinical Research Associate II role. Highlight relevant experience, especially in clinical monitoring and site management, and don’t forget to mention your understanding of GCP and regulations!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about clinical trials and how your skills align with our mission at StudySmarter. Keep it concise but impactful!
Showcase Your Soft Skills:We love candidates who can build positive relationships! In your application, highlight your communication and collaboration skills, as these are key for working with investigational sites and project teams.
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining the StudySmarter team!
How to prepare for a job interview at Evestia Clinical
✨Know Your Stuff
Make sure you brush up on your knowledge of Good Clinical Practice (GCP) and clinical trial regulations. Be ready to discuss how you've applied these principles in your previous roles, as this will show that you understand the importance of compliance and participant safety.
✨Showcase Your Experience
Prepare specific examples from your past work that highlight your skills in site management and monitoring. Think about challenges you've faced and how you resolved them, as well as any successful collaborations with project teams or investigational sites.
✨Ask Smart Questions
Come prepared with insightful questions about the company's approach to clinical trials and how they support their sites. This not only shows your interest in the role but also helps you gauge if the company’s values align with yours.
✨Be Personable
Building positive relationships is key in this role, so let your personality shine through during the interview. Be friendly and approachable, and demonstrate your ability to communicate effectively with various stakeholders.
