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The Clinical Research Coordinator is responsible for supporting Investigator Site staff in conducting clinical research studies according to project-specific requirements and regulatory guidelines. The role involves assisting in study-related activities at the site level, ensuring compliance with protocols, Standard Operational Procedures (SOPs), and international and local clinical trial regulations (ICH GCP Guidelines, CFR, GDPR, HIPAA, etc.).
Job Responsibility:
Serve as a primary point of contact for Investigator Site Staff and Sponsor representatives
Support organization and execution of monitoring visits and audits at the Investigator Site, including arranging visits, preparing documentation, and coordinating with relevant site personnel
Enter patient-specific data into applicable clinical systems (eCRF, ASM, etc.) and assist in resolving data queries
Arrange and coordinate patient visits and communication
Collaborate with external service providers, such as central laboratories and couriers
Maintain assigned sections of the Investigator Site File and patient documentation
Participate in internal meetings and teleconferences
Assist with additional study-related tasks as per the Investigator’s requirements
Report any issues encountered during site operations to the Line Manager
Prepare reports on completed activities as per established timelines
Perform a wide range of administrative tasks connected to the assigned studies, mainly working with eCRF (data entry, query resolution), ISF maintenance, being the first point of contact for the CRA, monitoring visit support, etc.
Perform other duties as assigned by the direct Line Manager.
Requirements:
Bachelor's degree in a relevant field such as business administration, project management, or a related discipline
Proven experience in a similar role or environment, with a strong focus on oncology project support – oncology experience is a must to be considered for this role
Strong analytical skills and attention to detail, with the ability to work effectively in a team
Excellent communication and interpersonal skills, with a collaborative approach to problem-solving
Proficiency in relevant software applications and tools to support project execution
High level of English and Polish
Office based position in Gliwice/Bytom.
What we offer:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.