Clinical Research Associate - Poland (Warsaw/ Lodz/ Trojmiasto / Koszalin / Szczecin/ Poznan/Bydgoszcz)- FSP

Overview

Parexel is seeking a Clinical Research Associate (CRA) to join its FSP Clinical Operations team in Northern Poland as an individual contributor, acting as the primary site contact and site manager across all phases of clinical research studies.

What you'll do

• Serve as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility for allocated sites and developing strong site relationships that ensure continuity through every phase of the trial.
• Perform clinical study site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, local laws and regulations, the protocol, the Site Monitoring Plan, and associated documents.
• Gain an in-depth understanding of the study protocol and related procedures.
• Coordinate and manage tasks in collaboration with other sponsor roles to achieve Site Ready status, and provide input on site selection and validation activities.
• Perform remote and on-site monitoring and oversight using a range of tools to ensure that data generated at site are complete, accurate and unbiased, and that subjects' rights, safety and well-being are protected.
• Conduct site visits, including validation, initiation, monitoring, and close-out visits, and record clear, comprehensive, and accurate visit and non-visit contact reports in a timely manner.
• Collect, review, and monitor required regulatory documentation for study start-up, study maintenance, and study close-out.
• Communicate with investigators and site staff on protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits and inspections, and overall site performance.
• Identify, assess, and resolve site performance, quality, or compliance problems, escalating in line with the defined CRA Escalation Pathway in collaboration with the Clinical Research Manager and Partner Line Manager.
• Manage and maintain information and documentation in the Clinical Trial Management System, the electronic Trial Master File, and other systems as appropriate, within required timelines.
• Contribute to CRA team knowledge as a process subject matter expert, buddy or mentor, and by sharing best practices.
• Support and/or lead audit and inspection activities as needed, and perform co-monitoring visits where appropriate.
• Complete the required training curriculum, submit timesheets and expense reports accurately as required, keep your CV updated, and maintain a working knowledge of, and comply with, Parexel and client processes, ICH-GCPs, and other applicable requirements.

What you'll need

• Proven skills in site management, including management of site performance and patient recruitment.
• A demonstrated high level of monitoring skill with independent professional judgement.
• The ability to understand and analyze data and metrics, and to act on them appropriately.
• A solution-oriented approach to complex issues, with root cause analysis and the implementation of preventive and corrective actions.
• Effective time management, organizational, interpersonal, conflict management, and problem-solving skills.
• Strong verbal and written communication skills, including the ability to understand and present technical information effectively.
• The ability to work effectively in a matrix, multicultural environment and to build culturally sensitive working relationships.
• A customer focus, with a quality and compliance mindset.
• A positive, growth mindset and a self-driven approach, with the ability to work independently.
• A high sense of accountability and urgency, with the ability to set priorities and handle multiple tasks simultaneously in a changing environment.
• Good IT skills, including MS Office, clinical IT applications on computer, tablet, and mobile devices, and the ability to adapt to new applications.
• A professional demeanor and communication consistent with organizational policies and practices.
• Fluent in the local language and in English, both verbal and written, with excellent communication skills.
• Good understanding and working knowledge of clinical research, the phases of clinical trials, current GCP/ICH, and country clinical research law and guidelines.
• Good understanding of global and country/regional clinical research guidelines and the ability to work within these guidelines.
• Hands-on knowledge of Good Documentation Practices.
• Minimum 2 years of direct site monitoring experience in bio/pharma/CRO.
• Current driver's license.
• Ability to travel domestically and internationally for approximately 65%-75% of working time, with travel of approximately 2-3 days per week.
• Specific monitoring and therapeutic area experience requirements may vary depending on the country or study needs.

Nice to have

• Bachelor's degree in science (Biotechnology, Pharma, Biology).

Details

• Location: Northern Poland (Trojmiasto, Poznan, Koszalin).
• Individual contributor role within the FSP Clinical Operations team.
• Travel approximately 65%-75% of working time, approximately 2-3 days per week.