Senior Clinical Research Associate, 0.5 FTE - Belgium (Remote) - FSP

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 0.5 FTE Senior Clinical Research Associate (SCRA) to join our team in Belgium in a remote/home-based capacity. As a Senior Clinical Research Associate, you will play a critical role in advancing oncology research by ensuring clinical trial quality, data integrity, patient safety, and regulatory compliance at the site level. Working within a sponsor-dedicated model, you will oversee monitoring activities across assigned investigator sites, collaborating closely with site personnel, investigators, and project teams to support successful study delivery. This position offers the opportunity to contribute directly to the development of innovative therapies while building strong partnerships with sites and stakeholders. You will leverage your expertise in oncology clinical trials, including RECIST criteria, to support study execution through a combination of remote and on-site monitoring activities. Your work will help ensure that studies remain inspection-ready, compliant, and focused on delivering high-quality outcomes for patients. You will join a collaborative, growth-oriented environment where your contributions are highly visible and where continuous learning, professional development, and meaningful impact are part of everyday work. Key Responsibilities Ensure compliance with study protocols, ICH-GCP guidelines, regulatory requirements, and company procedures across assigned sites. Evaluate site performance and provide recommendations for site-specific actions, escalating significant issues and supporting development of corrective action plans when required. Verify that informed consent processes are appropriately conducted and documented for each study participant. Assess patient safety and clinical data integrity by identifying protocol deviations, violations, pharmacovigilance concerns, and other site-level risks. Conduct monitoring activities through remote and on-site methods in accordance with the Clinical Monitoring Plan and Study Monitoring Plan. Perform source document review and verification, ensuring clinical data entered into case report forms is accurate, complete, and supported by source documentation. Manage protocol deviation reporting, follow-up activities, and timely resolution of data queries. Review investigational product accountability, storage, security, dispensing, administration, reconciliation, and related documentation where applicable. Document monitoring findings and study activities through monitoring reports, follow-up letters, communication logs, and other required study documentation. Ensure study activities are performed by appropriately trained and delegated site personnel. Maintain accurate tracking of observations, action items, site status, and study progress within required systems and tracking tools. Review site documentation, training compliance, delegation logs, enrollment logs, accountability records, and other essential study records to ensure ongoing inspection readiness. Participate in investigator meetings, sponsor meetings, monitoring meetings, and project team discussions as required. Collaborate with the primary Site Manager and key stakeholders to support study objectives, deliverables, and timelines. Candidate Profile You’ll thrive in this role if you bring: Strong networking, relationship-building, and stakeholder management skills Experience working within clinical research and regulated environments The ability to communicate effectively with internal and external stakeholders at all levels A patient-focused mindset and commitment to quality, compliance, and data integrity Comfort working with clinical trial systems, monitoring processes, and evolving technologies The flexibility to adapt to changing priorities while maintaining focus on study objectives and timelines Required Qualifications Bachelor’s degree, Registered Nurse (RN), or an equivalent combination of education, training, and experience Experience in clinical research monitoring with oncology trial experience and knowledge of RECIST criteria Knowledge of ICH-GCP, applicable regulatory requirements, and clinical trial processes Experience conducting on-site and remote monitoring activities Strong verbal and written communication, presentation, organizational, and interpersonal skills Ability to build and maintain effective relationships with investigator site personnel and study stakeholders Proficiency in the local language Advanced-level or fluent English language skills Preferred Qualifications Experience working within sponsor-dedicated clinical research environments 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. #J-18808-Ljbffr