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

Parexel is seeking sponsor‐dedicated Senior Clinical Research Associates to be based in Belgium. Experience in oncology trials and RECIST criteria is essential. The Senior CRA will be responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan (SMP), largely virtually to supplement on‑site visit requirements. The Senior CRA will collaborate with the Site Manager to assure protocol compliance, inspection readiness, and coordination with local institutions and investigators. Oversight of Monitoring Responsibilities and Study Conduct Ensure regulatory, ICH‑GCP, and protocol compliance; use judgment to evaluate overall performance of site and staff; provide recommendations and develop action plans. Verify informed consent procedures are adequately performed and documented for each subject. Maintain confidentiality of subjects and assess factors affecting safety and data integrity, including protocol deviations, violations, and pharmacovigilance issues. Conduct monitoring activities in accordance with the Clinical Monitoring Plan (CMP) or SMP, using on‑site and remote methods where allowed. Conduct source document review and verify that clinical data entered in the CRF is accurate and complete. Manage reporting of protocol deviations and follow up. Apply query resolution techniques remotely and on‑site, guiding site staff to closure within agreed timelines. Perform investigational product (IP) inventory, reconciliation, and review storage and security. Ensure IP is dispensed and administered according to protocol; verify issues or risks related to blinded or randomized information. Apply GCP and local regulations to ensure IP is appropriately labelled, imported, released, and returned. Manage reporting and follow‑up of identified issues to resolution. Document activities via follow‑up letters, monitoring reports, communication logs, and other required project documents per SOPs and CMP/SMP. Ensure all activities are carried out by site personnel who are properly delegated and trained. Enter data into tracking systems to record observations, status, and action items; understand project scope, budgets, and timelines. Review data entry timeliness, missing pages, outstanding queries, and timelines for database locks. Review site signature sheet and delegation of duties log for updates and training compliance. Conduct follow‑up on escalated adverse event monitoring (AEM) report queries. Verify that site and external facilities, equipment, and supplies are adequate and have valid expiry dates. Verify that site‑specific logs (e.g., Site Visit Log, Screening and Enrollment Log, Signature Sheet) are complete and up to date. Collaboration Collaborate with the primary Site Manager, acting as the primary liaison with site personnel. Prepare for and attend investigator meetings and sponsor face‑to‑face meetings. Participate in global clinical monitoring and project staff meetings, including client representation when applicable. Skills Networking and relationship‑building skills; effective communication with internal and external stakeholders. Adaptability to changing technologies and processes; overcome barriers during implementation. Excellent verbal and written communication, presentation, and interpersonal skills. Build effective relationships with investigator site staff and other stakeholders. Proficiency in the local language and advanced fluency in English. Education Bachelor’s degree or Registered Nurse (RN) in a related field, or an equivalent combination of education, training, and experience. #J-18808-Ljbffr