CRA II

CRA II - Sponsor Dedicated - Madrid, Spain. Min 2 years of experience as CRA. Syneos 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. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for. Whether you join us in a Functional Service Provider partnership or a Full‑Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate about Sneakers; article? (But we apply to correct content) & change lives. Responsibilities Performs 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 Pharmacoepidemiology Practice (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 develops action plans. Makes sure informed consent has been adequately performed and documented for each subject/patient, protects confidentiality, and assesses factors that might affect safety and data integrity at the investigator/physician site (e.g., protocol deviation, pharmacovigilance issues). Assesses site processes per the Clinical Monitoring/Site Management Plan (CMP/SMP); conducts source document review, verifies data entered in case report forms, applies query resolution techniques, and drives query resolution to closure. May perform investigational product inventory/reconciliation,reto? verify dispensing and administration per protocol, and ensure appropriate labeling, import, release/return. Routinely reviews the Investigator Site File for accuracy, timeliness, and completeness; reconciles with the Trial Master File; ensures compliance with archiving requirements. Documents activities via letters, trip reports, communication logs, and other project documents; supports subject recruitment, retention, and awareness; enters data into tracking systems. Manages site‑level activities and communications to ensure project objectives and timelines are met, adapting quickly to changing priorities. Acts as primary liaison with study site personnel or collaborates with Central Monitoring Associate; ensures all assigned sites and team members are trained and compliant with applicable requirements. Prepares for and attends investigator meetings and sponsor face‑to‑face meetings; participates in global project staff meetings and training sessions. Provides guidance toward audit readiness standards and supports preparation for audits and required follow‑up actions. Supports sites throughout the study lifecycle, providing data collection, collaborating with sponsor affiliates, medical science liaisons, and local country staff; may train junior staff. Qualifications Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience. Four years of general pharmaceutical industry or clinical research experience, including 2–3 years of monitoring experience. Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements. Strong computer skills and ability to embrace new technologies. Excellent communication, presentation and interpersonal skills. Ability to manage up to 75% travel. US ONLY: May be required to provide medical/personal information for site access; compliance with the Employee Privacy Notice is required. Failure to provide may result in barring from entry and affect employment. Seniority Level Mid‑Senior level Employment Type Full‑time #J-18808-Ljbffr