Job Title:
Clinical Research Associate II
-----------------------------------
This role involves working in the field of clinical research as a key member of a team responsible for managing and conducting clinical trials. The primary objective is to ensure that all clinical trials are conducted in accordance with the protocol, Good Clinical Practice (GCP), and regulatory requirements.
Responsibilities:
1. Management of clinical trials according to protocols and monitoring plans.
2. Knowledge and understanding of protocols and case report forms.
3. Maintaining contact with investigators.
4. Providing support to sites on study-related issues.
5. Informing investigators about study timelines, enrolment expectations, and fees.
6. Conducting initiation visits and monitoring visits in accordance with GCP and monitoring plans.
7. Preparing documentation for investigator and institution fees.
Requirements:
* A degree in life sciences or healthcare related field or equivalent work experience.
* Minimum one year of independent monitoring experience in oncology (mandatory).
* Understanding of clinical trial design, execution, and operations.
* Knowledge of international standards (GCP/ICH) and local regulations.
* Excellent communication skills, ability to manage multiple priorities, and computer literacy.
* Proven people management skills with expertise in teamwork.
* Fluency in English and Polish languages.
Benefits:
* Competitive salary package.
* Annual leave entitlements.
* Range of health insurance offerings.
* Retirement planning options.
* Employee Assistance Programme.
* Life assurance.
* Optional benefits including childcare vouchers, bike purchase schemes, gym memberships, travel passes, health assessments, etc.
Work Environment:
At our organization, we value diversity, inclusion, and belonging. We strive to provide an inclusive environment for all employees and applicants. Our company promotes equal opportunities and does not discriminate against any individual based on their background, gender identity, disability status, or other protected characteristics.