FirmaTimshel Sp. z o. o.
For our Client - Polish CRO specialized in site identification, protocol feasibility, startup, contracting, and clinical operations from phase I to IV, we are looking for:
Clinical Research Associate II.
- Communication with the medical site staff including coordinators, clinical research physicians and their site staff;
- Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
- Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements;
- Verification that the investigator is enrolling only eligible subjects;
- Regulatory document review;
- Medical device and/or investigational product/drug accountability and inventory;
- Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
- Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement;
- Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
- Minimum of a bachelor’s degree; Health or life science related field preferred;
- 2 years of proven CRA experience;
- Willing to travel approximately 60-80% nationally;
- Familiarity with Microsoft® Office;
- Strong communication and presentation skills.
- Permanent contract;
- Opportunity for development;
- Competitive salary and benefits package;
- Medical care;
- Performance annual bonus;
- Benefit System.
PLEASE ADD TO YOUR RESUME:
I hereby agree to the processing of my personal data for recruitment by Timshel Sp. z o.o. for the position of CRA II. I hereby agree to the processing of my personal data for recruitment by Timshel Sp. z o.o., for the purpose of other vacancies compliant with my qualifications, no longer than three years from the day of application.
WE KINDLY INFORM THAT WE ONLY CONTACT SELECTED CANDIDATES.