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 Trial Coordinator (CTC) to join our team in Warsaw office based 3 days weekly.
As a Clinical Trial Coordinator, you will play a key role in supporting the Clinical Research Manager and wider team throughout the full life cycle of a clinical study, from study start-up to study closure. Working alongside assigned line management and day-to-day direction from the client, you will keep trial activities organized, documented, and compliant, managing the administrative, document, regulatory, and budgeting activities that underpin the delivery of high-quality clinical research.
This position offers the opportunity to build deep operational expertise across the clinical trial life cycle while interacting with internal and external stakeholders, including study sites, investigators, vendors, and cross-functional teams. You will bring a proactive approach to problem solving and help keep study objectives, deliverables, and timelines on track, supporting the efficient delivery of trials that ultimately benefit patients and the development of new therapies.
You will join a collaborative, growth-oriented environment where your contributions are visible and where continuous learning, professional development, and knowledge sharing are part of everyday work.
Key Responsibilities
Support the Clinical Research Manager and team members across the full study life cycle, from study start-up through study closure.
Manage trial and site administration, including tracking essential documents, tracking and reporting safety reports, ensuring the collation and distribution of study tools and documents, and updating clinical trial databases (CTMS) and trackers.
Coordinate clinical and non-clinical supply management in collaboration with other country roles, and manage labeling requirements, including coordinating and signing translation change requests.
Prepare documents and correspondence, and collate, distribute, ship, and archive clinical documents.
Support electronic Trial Master File (eTMF) reconciliation, execute the eTMF Quality Control Plan, and update manuals and study documents such as patient diaries and instructions.
Obtain translations of study documents and document the proper destruction of clinical supplies.
Prepare Investigator trial file binders and provide and collect forms and lists from investigators for site evaluation, validation, and site start-up.
Obtain, track, and update study insurance certificates.
Support the preparation of submission packages for IRB/ERC and support regulatory agency submissions.
Publish study results for Global Clinical Trial Operations and Regulatory Affairs where required…