CRA II

CRA II - Sponsor Dedicated – Madrid, Spain Updated: January 12, 2026Location: Madrid, SpainJob ID: Job 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 GPP compliance, evaluating overall site performance and providing recommendations. Verifies informed consent process for each subject, maintains confidentiality, and assesses safety and data integrity risks at investigator sites. Assesses site processes, conducts source document review, verifies accurate data entry on CRFs, resolves queries, and verifies electronic data capture compliance. Performs investigational product inventory, reconciliation, storage review, and ensures correct dispensing and administration to subjects. Reviews and reconciles Investigator Site Files with the Trial Master File, ensuring archiving meets local guidelines. Documents activities via letters, trip reports, and communication logs, supports recruitment, retention and awareness strategies as required. Manages site‑level activities, budgets and timelines, adapts quickly to changing priorities, and ensures project objectives are met. Acts as primary liaison with study site personnel and collaborates with Central Monitoring Associates, ensuring training and compliance. Prepares for and attends investigator meetings and sponsor face‑to‑face meetings, and participates in global clinical monitoring meetings and training sessions. Provides guidance toward audit readiness, supports audit preparation and follow‑up actions. Maintains knowledge of ICH/GCP regulations and company SOPs, completes required training, and supports Real World Late Phase studies and site lifecycle support. Collaborates with Sponsor affiliates, medical science liaisons and local staff, and may train junior staff where requested. Identifies and communicates out‑of‑scope activities to the Lead CRA/Project Manager and proactively suggests potential sites based on local knowledge. Qualifications Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience. At least 4 years of general pharmaceutical industry or clinical research experience, and 2‑3 years of monitoring experience. Knowledge of GCP/ICH guidelines and applicable regulatory requirements. Proficient computer skills and ability to adopt new technologies. Excellent communication, presentation and interpersonal skills. Availability to travel up to 75% of the time. US‑ONLY: Compliance with site‑specific medical and personal information requirements as disclosed under Syneos Health’s Employee Privacy Notice. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. 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. The Company also complies with the EU Equality Directive and will provide reasonable accommodations as required. #J-18808-Ljbffr