Clinical Research Associate
hace 10 días
Toledo
Position: Clinical Research Associate Location: Azuqueca de Henares. Experience: 2 to 4 years in similar roles. Do you want to know more? INSUD PHARMA operates throughout the entire pharmaceutical value chain, providing specialized knowledge and experience in scientific research, development, manufacturing, sales, and marketing of a wide range of active pharmaceutical ingredients (API), finished dosage forms (FDF), and branded pharmaceutical products, adding value to both human and animal health. INSUD PHARMA’s activity is structured into three synergistic business areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with more than 9,000 professionals in over 50 countries, 20 state-of-the-art facilities, 15 specialized R&D centers, 12 commercial offices, and over 35 pharmaceutical subsidiaries, serving 1,150 clients in 96 countries worldwide. INSUD PHARMA believes in innovation and sustainable development. Are you ready to be a #Challenger? The challenge! Collaborate with Clinical Development Leaders to execute assigned trials aligned with the product development plan. Take ownership of trial execution, reporting, and evaluation, ensuring compliance with GCP and applicable regulations. Support clinical trial activities according to ICH/EMA/FDA and other relevant guidelines. Participate in the selection of CROs and external vendors; oversee contracted activities (cost, quality, timelines). Review key trial documentation (e.g., Protocol, ICF, monitoring oversight, study report). Work closely with sponsor teams, CROs, and site staff in multidisciplinary environments. Oversee monitoring documentation (e.g., MVRs), SDV quality, and site readiness/compliance. Oversee training of site staff on protocols, safety reporting, and GCP. Oversee IP handling, storage, and accountability at sites. Proactively identify risks and drive corrective and preventive actions (CAPA). Coordinate internal CHEMO activities linked to trial conduct (e.g., investigational product shipments). Partner with cross-functional teams (Pharm Dev, Regulatory, PV, Project Management) to support execution. Contribute to GCP system maintenance through SOP development/review. What do you need? University degree in a Life Sciences discipline (mandatory) 2+ years in a similar CRA/clinical trial oversight role Experience in global clinical development and trial implementation (site selection/management, monitoring activities) Remote and on-site monitoring exposure, including risk-based monitoring (RBM) Strong understanding of ICH-GCP , FDA , EMA , and local regulatory requirements Skilled in identifying/documenting/escalating AEs/SAEs Experience preparing and reviewing study documentation Willingness to travel ~10% Languages Fluent English required Spanish (communicative level) is a plus; other languages are an asset Skills Strong cross-functional collaboration in international settings Proactive, hands-on, “can-do” mindset with strong ownership Excellent organization, attention to detail, communication, and time management Comfortable with Microsoft Office for reporting/documentation Sound judgment, curiosity, and willingness to learn Our benefits! ⏰Flexible entry schedule from Monday to Friday (full-time, 40 hours). Permanent contract Attractive salary package.
