Are you looking for a role where you can truly make a difference? Do you thrive in a dynamic, collaborative environment where your ideas are valued? If so, you might be our next Excellence Maker! Join Aurevia Poland team in our journey of quality excellence.
We are looking for an experienced Clinical Research Associate (CRA) for a permanent, full-time position, preferably in Poland. You will join our CRO Services team in Poland, which serves pharmaceutical, biologics and medical device manufacturers and clinical trial sponsors in various assignments related to generating and demonstrating clinical data. Our international customer base consists of large established global players, start-up companies and everything in between.
We offer you a versatile and challenging position with a lot of responsibility in the field of clinical trials. As a new Excellence Maker, you will join our team of outstanding quality experts who offer you an international professional network to grow and succeed in your position and career.
Your Key Responsibilities:
Serve as the contact for sites and investigators participating in studies
Plan and perform feasibility studies
Plan and perform the pre-study-, initiation-, monitoring- and close-out visits including writing visit reports, filing and collecting trial documentation
Plan and conduct investigator and site-staff training
Collecting and filing of study documents prior to study start and during the conduct of the study
Source data verification according to study protocol/ monitoring guidelines
Maintenance of the Trial Master File (TMF) and Investigator Site File (ISF)
You will also be involved in negotiation of contracts with sites and other applicable institutions, preparation of study documents, and submissions
You will participate in writing and reviewing internal SOPs and routines within the area of responsibility and interface areas
Interaction with internal parties and colleagues to drive action and improvement where needed
Qualifications:
Technical / biological / life science / clinical education (e.g. degree in biomedicine, pharmacist or nurse)
Prior work experience of at least 5 years full time as Clinical Research Associate in clinical trials of investigational medicinal products, experience in medical devices clinical investigations and/or in vitro diagnostic clinical performance studies is a benefit
Experience in applying relevant regulations and standards, such as GCP, ISO 14155, ISO 20916
Experience in coordinating applications to authorities
Excellent organizational, communication and influencing skills
A positive service attitude
Ability to manage and support the activities of investigational site staff and to contribute to the team
Ability to anticipate and resolve investigational site related problems
Ability to handle multiple tasks and projects simultaneously and work independently
Experience in using electronic documentation management systems and eCRF/eTMF/CTMS
Good skills in M365 tools: e.g. Excel, Word and Powerpoint
Excellent Polish and English language skills (oral and written)
Ability to travel, a driver’s license is seen as a benefit
What We Offer: At Aurevia, we are the excellence makers — a team of experienced experts in healthcare and health-tech standards and quality. Together, we drive healthcare, pharmaceutical, and medical technology development with a future-focused approach aligned with client needs. Guided by our commitment to care, we deliver quality to the industry and pave the way for safer, more effective patient care worldwide. Join Aurevia — a fast-growing, modern company! Our growth and dynamic environment provide an excellent platform for professional development and innovation. Our employees enjoy a high degree of autonomy and the opportunity to shape the direction of their work. We support work-life balance through flexible working arrangements. We offer a compensation package that reflects your skills and experience. In addition, we provide a comprehensive benefits package (health insurance, cozy office, flexible working hours, wellness allowance and occupational pension).
The workplace is located in our office in Tychy or in hybrid model in Poland. We offer modern office spaces and a pleasant working environment. At Aurevia, you become part of a collaborative and approachable team!
If you have any questions about the position, feel free to reach out to:
Tadeusz Baron
Partnerships & Strategy Director
Country Manager, Poland
tadeusz.baron@aurevia.com
+485 1 334 4446
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