Description CRA I/II_ Barcelona_Sponsor dedicatedSyneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need.

Why Syneos

Health• We are passionate about developing our people, through career development and progression; technical and therapeutic area training; Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job ResponsibilitiesPerforms site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans.

Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.For the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processesConducts Source Document Review of appropriate site source documents and medical recordsVerifies required clinical data entered in the case report form (CRF) is accurate and completeApplies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelinesUtilizes available hardware and software to support the effective conduct of the clinical project data review and captureVerifies site compliance with electronic data capture requirementsMay perform investigational product (IP) inventory, reconciliation and reviews storage and security.



Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulationsDocuments activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.

Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets.May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA). Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.Participates in general clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.For Real World Late Phase, the CRA I will use the business card title of Site Management Associate I.





Site support throughout the study lifecycle from site identification through close-outKnowledge of local requirements for real world late phase study designsChart Abstraction activities and data collectionCollaboration with Sponsor affiliates, medical science liaisons and local country staffQualifications:Bachelor’s degree or RN in a related field or equivalent combination of education, training and experiencePrevious experience as an independent CRA required.Oncology experience will be preferred.Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirementsMust demonstrate good computer skills and be able to embrace new technologiesExcellent communication, presentation and interpersonal skillsAbility to manage required travel of up to 75% on a regular basisGet to know Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.Learn more about Syneos Health.Further, nothing contained herein should be construed to create an employment contract. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.Summary Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols.

Utilizes data analytics and risk-based monitoring techniques to identify potential issues and trends, ensuring that trials are conducted in accordance with established clinical practices. Collaborates with site teams to develop and implement tools, procedures, and processes that enhance quality monitoring and support the overall success of clinical trials. Delivers work of limited scope, typically smaller, less complex projects.

📌 Cra Oncology (Madrid)
🏢 Syneos Health
📍 Madrid