When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
About Parexel
Parexel is a leading global clinical development partner delivering insight-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.
We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart®.
About The Role
We are seeking a Clinical Research Associate (CRA) to join our FSP Clinical Operations team in Northern Poland (Trojmiasto, Poznan, Koszalin) as an individual contributor. In this role, you will act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility for your allocated sites.
Working closely with sponsors, investigators, and site personnel, you will build strong, lasting site relationships and ensure continuity through every phase of the trial, from site selection and validation through to close-out. You will carry out remote and on-site monitoring to ensure that data generated at site are complete, accurate and unbiased, and that subjects' rights, safety and well-being are protected.
This position offers the opportunity to contribute directly to the development of innovative therapies while building your expertise as a process subject matter expert, buddy, and mentor to fellow CRAs. You will support audits and inspections, and your work will help ensure that studies remain inspection-ready, compliant, and focused on high-quality outcomes for patients.
You will work highly independently across multiple protocols, sites, and therapy areas, joining a collaborative, growth-oriented environment where your contributions are visible and where continuous learning, professional development, and meaningful impact are part of everyday work.
Key Responsibilities
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…