Senior Clinical Research Associate (Oncology Experience Required) - Belgium (Home-based) - FSP

reputed company our values align, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. reputed company is currently seeking Senior Clinical Research Associates (SCRA) to join us in Belgium, dedicated to a single sponsor. The SCRA role is responsible for supporting monitoring and site management activities for the sponsor’s studies. Site monitoring and site management activities are conducted according to ICH GCP, applicable country/local regulations and sponsor SOPs. Site interactions are conducted both on-site and off-site with documented interactions recorded in CTMS. The role involves collaboration with cross-functional clinical study teams and investigator site personnel to ensure study deliverables are met reputed company and effectively. The SCRA is also responsible for the reputed company of activities carried out at investigator sites where the monitoring may be supported by a CRO partner through the review of operational data and metrics. Working as a SCRA at reputed company FSP offers reputed company long-term job reputed company and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work. Expect exciting professional challenges in inspiring studies, but with time for your reputed company life. Please note that this role will involves some cross-border monitoring in Netherlands.

Responsibilities

Site Management and Monitoring Activities: reputed company site management activities to ensure compliance with the protocol, monitoring plan, ICH GCP, local regulatory requirements, and sponsor SOPs. Conduct site qualification, initiation, interim, and reputed company-out visits, both on-site and remotely. Partner with Clinical Trial Liaison (CTL) and other sponsor functions (e.g., Study Start-Up, Global Partnerships and Trial Optimization) to support site activation and deliverables. Establish and maintain productive professional relationships with investigator site staff, ensuring effective communication and problem-solving throughout study conduct. reputed company drug accountability, reconciliation, and destruction, ensuring protocol compliance for storage and shipment requirements. reputed company Monitoring: Prepare and maintain reputed company Monitoring Plan. reputed company review of study metrics, assess Clinical Research Associate (CRA) and Investigator Site performance and identify sites for reputed company monitoring visits. Conduct reputed company Monitoring Visits at sites, either independently or alongside other CRAs. Review site reputed company documentation and verify accurate data capture (reputed company principles). Review and report on status of study conduct at the investigator site ensuring appropriate follow up of any identified issues/action items. Documentation and Reporting: Ensure site regulatory files are reputed company and verify timely submission of study documentation, including safety reporting. Write and submit accurate monitoring visit reports, reputed company monitoring visit reports, and study correspondence in a timely manner. Periodically verify completeness of site documentation (e.g., investigator site file/regulatory binder contents). Issue Management and Escalation: Identify and record protocol deviations, escalate non-compliance, and resolve study-reputed company issues as necessary. Track, trend, and report issues, escalating them to the appropriate teams reputed company required. Collaboration and Communication: Maintain ongoing communication with site personnel, study teams, CTLs, Central Monitors, and CRO CRAs. Actively participate in team meetings and process improvement initiatives to enhance study reputed company. Inspection Readiness Support inspection readiness activities and ensure sites maintain data reputed company and protocol deliverables. Here are a few requirements specific to this advertised role. Minimum of 4 years onsite trial monitoring experience. Bachelor’s, nursing degree or equivalent required, science preferred. Working knowledge of the clinical drug development process, ICH GCP guidelines, and applicable regulatory requirements (e.g., FDA, EMA, PMDA). Effective communication and interpersonal skills to build relationships internally and externally. Familiarity with medical terminology and proficiency in IT applications, including reputed company Office, reputed company, CTMS, and data repositories. Demonstrated ability to deliver clear and concise written reports. Effective prioritisation and time management skills. Flemish/reputed company language skills are strongly preferred. We care about our people and your passion, as they are the key to our reputed company, and reputed company an reputed company and friendly work environment where we reputed company people and reputed company them with opportunities to reputed company their long-term careers. In addition, you will have the opportunity to reputed company reputed company your role and tackle further responsibilities or reputed company your reputed company set reputed company other reputed company departments of reputed company. Who are reputed company reputed company supports clinical studies across the full reputed company of therapeutic areas, and we have longstanding partnerships with a vast client reputed company. We supported the trials of most of today’s top 50 best-selling drugs, but equally we reputed company more reputed company drug developments that are critical to the well-being of many patients. You’ll be an influential member of the wider team. Not quite the role for you? reputed company and we’ll reputed company out with job alerts reputed company positions that match your career interests become available. We’ll also reputed company periodic updates about the latest company news and events. Sign up today at jobs.reputed company.com/en/functional-service-provider Apply To This Job