Clinical Research Associate II - FSP Team - Salamanca Area
FortreaMadrid, Comunidad de Madrid, EspañaHace 5 días
Descripción del trabajoUniversity or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate. Thorough understanding of ICH GCP Guidelines and local regulatory requirements. Thorough knowledge of monitoring procedures. Fluent in local office language and in English, both written and verbal. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Minimum of 2 years of Clinical Monitoring experience. Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines. Therapeutic area expertise required : oncology and hematology, CAR‑T and SNC. Additional expertise in other areas is a plus. Sites expertise : preferred experience and familiarity with the Hospital of Salamanca. Good understanding of the principles of ICH GCP, ISO 14155 (if applicable) and local regulatory requirements. Good analytical and negotiation skills. Experience using e‑clinical systems (e.g., clinical trial management system CTMS). Will involve outside of normal office hours as required by the role. Travel requirement is 60% of the time (traveling to study sites).
Clinical Research Associate II - FSP Team - Salamanca Area
Fortrea Madrid, Community of Madrid, Spain
Summary of Responsibilities
- Site management for clinical studies is conducted in accordance with Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans, and sponsor requirements. This includes verifying that study training records are complete and accurate.
- Site monitoring responsibilities cover all phases of a clinical trial—Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits—ensuring compliance with regulatory and protocol standards.
- Project plans related to clinical monitoring are prepared and implemented to align with study timelines and deliverables.
- Subject protection is ensured through eligibility reviews and verification that informed consent procedures and protocol requirements are followed in accordance with regulatory expectations.
- Data integrity is safeguarded through thorough source document review, source data verification, query generation and resolution, all performed using Fortrea or sponsor data management systems.
- Site regulatory documentation and eTMF / Sponsor files are maintained to be complete and current throughout the trial duration, ensuring audit readiness.
- Investigational Product inventory and accountability are confirmed to be accurate, with secure storage and handling per protocol. Additional responsibilities include supporting CRA performance metrics, acting as Lead CRA when assigned, and collaborating with study teams to meet project goals.
Qualifications (Minimum Required)
Experience (Minimum Required)
Preferred Qualifications
Physical Demands / Work Environment
Learn more about our EEO & Accommodations request here.
Seniority Level
Entry level
Employment Type
Full‑time
Job Function
Research, Analyst, and Information Technology
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Research Associate • Madrid, Comunidad de Madrid, España