The posting
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 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.
Candidate Profile
You'll Thrive In This Role If You Bring
- 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
Required Qualifications
- 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.
Preferred Qualifications
- Bachelor's degree in science (Biotechnology, Pharma, Biology)
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 230,000 to 260,000. 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.
