In a nutshell 📌
Position: Clinical Research Associate (CRA)
Location: Poland
Experience: Minimum 3 years in clinical trial monitoring
Want to know more? 👇
CROVELIS is launching a globally focused internal CRO to deliver exceptional clinical trial results. We are a high-growth, fast-paced, and agile organization that values teamwork, collaboration, and proactive problem-solving. At CROVELIS, diversity, creativity, and professional development are core pillars, and we foster a supportive, inclusive environment for all employees.
Ready to join our team? 💪
What are we looking for? 🔎
Key responsibilities:
- Participate in study and protocol design and planning, providing feedback to medical writers and clinical operations teams.
- Review CRFs, medical coding, and safety parameters.
- Develop and review study-related documents: protocols, informed consent forms, study manuals, and CRFs.
- Serve as the main point of contact for Principal Investigators (PI) and site staff.
- Build strong relationships with PIs, site staff, and sub-investigators, ensuring effective communication and collaboration.
- Conduct site qualification visits and prepare reports.
- Lead review and negotiation of study budgets and clinical trial agreements.
- Oversee distribution and collection of essential regulatory documents.
- Identify and mitigate risks to meet study milestones.
- Support patient recruitment and retention plans, ensuring materials and budgets are approved.
- Conduct site initiation, routine monitoring, and closeout visits, ensuring compliance with protocol and regulations.
- Identify and resolve study-related issues, manage deviations, and support data collection.
- Maintain accurate study documentation according to SOPs and regulations.
- Contribute to the development and maintenance of SOPs and quality control procedures.
- Review trip reports for junior CRAs, deliver internal training, and prepare presentations for investigator meetings.
- Participate in RFPs and other tasks assigned by the Clinical Trial Manager.
The challenge! 🚀
- Oversee clinical trial execution in compliance with GCP and regulatory requirements.
- Coordinate communication between PI, site staff, and internal teams.
- Manage multiple priorities in a fast-paced environment.
- Proactively evaluate and resolve issues.
What do you need? 🤓
- Bachelor’s degree in a scientific or healthcare-related field, nursing qualification, or relevant experience.
- Minimum 3 years’ experience as a CRA based in Germany.
- Proficiency in English, German, and French.
- Previous experience as Clinical Research Coordinator, Study Nurse, or Site Director (preferred).
- Knowledge of ICH-GCP, drug/device development processes, regulatory compliance, and study coordination.
- Familiarity with medical terminology, FDA regulations, and ICH guidelines.
- Excellent organizational, time management, and communication skills.
- Ability to work independently and manage priorities.
- Resilience, flexibility, and motivation.
- Proficient in Microsoft Office (Word, Excel, PowerPoint) and ability to learn new applications.
What’s the selection process? 🕵️
- Initial contact by email or phone.
- 1-2 virtual/onsite interviews.
- Ongoing communication about your application status.
🔷Not the right fit? Stay connected!🔷
Follow us on LinkedIn for future opportunities and updates! #CROVELIS #ClinicalTrials #TeamCROVELIS #TalentCROVELIS
COMMITMENT TO EQUAL OPPORTUNITY
At CROVELIS, we promote equal opportunity and do not discriminate based on gender, ethnicity, religion, sexual orientation, disability, or any other status. We value diversity and foster an inclusive environment for all our team members.