Clinical Trial Coordinator Regulatory - Poland (Warsaw Office based) - FSP

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 under local legislation.
• Collaborate with finance and budgeting representatives on the development of country and site budgets, including split site budgets, and on the tracking and reporting of negotiations and maintenance of tracking tools.
• Support contract development, negotiation, approval, and maintenance, including updating contract templates in cooperation with the Legal Department.
• Manage payment calculation and execution for investigators, vendors, and grants, ensuring compliance with financial procedures and monitoring adherence to disclosures.
• Support budget closeout and obtain and process FCPA (Foreign Corrupt Practices Act) documentation in a timely manner.
• Organize meetings, including creating and tracking study memos, letters, and protocols, and support local investigator meetings, including invitations, materials, venue selection, and on-site support where applicable.
• Complete training assigned by the client and/or company, including general training requirements, SOPs, and system and process training, and adhere to company and client SOPs and processes.

Candidate Profile

You'll Thrive In This Role If You Bring

• Effective time management, organizational, and interpersonal skills, along with strong conflict management skills
• Effective communication with external customers, such as study sites and investigators
• A high sense of accountability and urgency, with the ability to set priorities and handle multiple tasks simultaneously in a changing environment
• A demonstrated commitment to customer focus
• The ability to work independently and a proactive attitude to solving problems and proposing solutions
• A positive and growth mindset
• The willingness to act as a buddy or mentor and share best practices to strengthen team knowledge
• The ability to work effectively in a matrix, multicultural environment and to build and maintain culturally sensitive working relationships

Required Qualifications

• A B.A. or B.S. degree or equivalent healthcare experience
• Minimum of 1-2 years of experience in clinical research or relevant healthcare experience (specific experience requirements may vary depending on the country)
• Good understanding of global and country or regional clinical research guidelines and the ability to work within these guidelines
• Hands-on knowledge of Good Documentation Practices
• ICH-GCP knowledge appropriate to the role
• Good IT skills, including use of MS Office and clinical IT applications, and the ability to adapt to new IT applications, with strong MS Excel skills
• Fluency in local language(s) and business proficiency in English, both verbal and written, with excellent communication skills

Preferred Qualifications

• A B.A. or B.S. degree in Life Sciences

Benefits and Compensation

• Premium salary.
• Attractive benefits.
• Car or car allowance.
• Medical care plan: Health, Dental & Vision.
• Life Assurance.
• Excellent work environment.
• Culture of teamwork and collaboration.
• People who motivate and face challenges together.
• Innovative technology.
• Excellent training.

The potential base pay range for this role is PLN 120,000 to 135,000.
The actual salary offered may vary within this range based on several factors, including the position and level offered, skills, education, training, experience, professional achievements, and location.
Some roles may also be eligible for additional incentives, bonuses, or other compensation programs.
Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions. 
We offer a comprehensive benefits package to eligible employees, which includes paid time off, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans. 

If this job does not sound like the next step in your career, but perhaps you know someone who would be a perfect fit, send them the link to apply.

We believe in flexibility, growth, and creating space for people to do their best work.

Join us and be part of a team where your contributions help shape the future of clinical research.