🕒 9 days ago
Manage clinical trial activities across global projects, conducting site monitoring and supporting study startup while maintaining site relationships, patient safety, data quality, and compliance with study standards.
Clinical Research Associate II
🕒 19 days ago
📍 🇵🇱 Warsaw - Hybrid🎹 Mid-level🧫 Clinical Research Specialist📢 🇵🇱 Polish Required📢 🇬🇧 English Required💼 Full-Time
Onsite Clinical MonitoringStudy StartupCRF ReviewSource Document Verification
📜 Description
- Conduct and report onsite monitoring visits.
- Support study startup and participate in feasibility research.
- Review CRFs, verify source documents, and resolve queries.
- Manage site communications and serve as a contact for in-house support services and vendors.
- Communicate study progress to internal project teams.
- Support regulatory submissions and prepare for audits and inspections.
🛠️ Requirements
- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- Experience in independent on-site monitoring in all types of visits is required
- Experience in gastroenterology TA is required
- Full working proficiency in Polish, English and in MS Office applications
- Ability to travel and a valid driver's license
✨ Benefits
- Extensive onboarding and mentorship program.
- Flexible working hours and additional days off.
- Life insurance.
- Medical insurance.
- Sports card.
- Lunch card.
- Opportunities for personal and professional growth.
- Permanent work agreement.
Full job description
Company Description
Why PSI?
Because we are not a huge corporation and people still matter here. Our managers and employees have autonomy in making decisions and creating an engaging work environment. We provide the operational freedom to make nuanced country and department-specific adjustments, adhering to our common goals and culture that unites us across six continents.
Learn more why you should join PSI here!
Job Description
As a CRA at PSI you will be involved in improving patients' lives while enjoying a variety of monitoring tasks and working on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.
Hybrid work with office in Warsaw.
You will:
- Conduct and report all types of onsite monitoring visits
- Be involved in study startup
- Perform CRF review, source document verification and query resolution
- Be responsible for site communication and management
- Be a point of contact for in-house support services and vendors
- Communicate with internal project teams regarding study progress
- Participate in feasibility research
- Support regulatory team in preparing documents for study submissions
- Prepare and participate on audits and inspections
Qualifications
- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- Experience in independent on-site monitoring in all types of visits is required
- Experience in gastroenterology TA is required
- Experience in neurology and oncology is a plus
- Full working proficiency in Polish, English and in MS Office applications
- Ability to travel and a valid driver's license
Additional Information
What we offer:
- We value your time so the recruitment process is as quick as 2 meetings!
- We'll prepare you to do your job at highest quality level with our extensive onboarding and mentorship program
- You'll have excellent working conditions - spacious and modern office in convenient location, and friendly, supportive team who love to hang out together
- You'll have permanent work agreement at a stable, privately owned company
- We care about our employees - aside from competitive salary, you'll have good work-life balance with flexible working hours and additional days off, life and medical insurance, sports card, lunch card
- We're constantly growing which means opportunities for personal and professional growth
Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.
Please provide your CV in English.
If you have any questions, don't hesitate to reach out to the recruiter at karolina.karaszewska@psi-cro.com or on Karolina Karaszewska | LinkedIn
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