About Syneos Health CRA
- Future RolesSyneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®. WORK HERE MATTERS EVERYWHERE We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; Job Responsibilities Performs site qualification, site initiation, interim monitoring, site management activities and close?site or remotely) ensuring regulatory, ICH?Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site?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 processes, Conducts Source Document Review of appropriate site source documents and medical records, Verifies required clinical data entered in the case report form (CRF) is accurate and complete, Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines, Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture,



Verifies site compliance with electronic data capture requirements.
May 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 regulations.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.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?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?For Real World Late Phase, the CRA I will use the business card title of Site Management Associate I. out Knowledge of local requirements for real world late phase study designs Chart Abstraction activities and data collection Collaboration with Sponsor affiliates, medical science liaisons and local country staff.
Qualifications Bachelor's degree or RN in a related field or equivalent combination of education, training and experience.
Must demonstrate good computer skills and be able to embrace new technologies.
US ONLY: As part of your employment with Syneos Health, you may be deployed to sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the sites with the information necessary for you to gain such access. Further, a site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such site requests as a condition of your employment with Syneos Health.
Get to know Syneos Health Over 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

📌 Urgente Clinical Trial Assistant (Barcelona)
🏢 Syneos Health
📍 Barcelona