CLINICAL RESEARCH ASSOCIATE

Position: Clinical Research AssociateLocation: Azuqueca de Henares.Experience: At least 2 to 5 years of experience.Want to know more?👇Insud Pharma is a recognized and respected company in the pharmaceutical and healthcare sector with over 40 years of history with more than 7,000 employees in 50 countries specialized in the research, development, manufacturing and marketing of active pharmaceutical ingredients and medicines for human and veterinary use. Chemo, an industrial area of the Insud Pharma group, is a world leader in R&D and manufacturing of more than 100 value-added active pharmaceutical ingredients and more than 122 drugs with more than 200 different product presentations. Chemo produces its own active pharmaceutical ingredients (API) as well as finished pharmaceutical products (FDF) covering the main therapeutic groups (Cardiology, Gastroenterology, Central Nervous System, Anti-infectives, Respiratory, Women's Health, Endocrinology, Dermatology and Urology)what are we looking for?🔎We are looking for a new Clinical Research Associate to join the R&D / Clinical Development team at our plant in Azuqueca de Henares.The challenge!🎯Collaborate with Clinical Development Leaders to execute assigned clinical trials, according to the requirements of the pharmaceutical product development plan.🎯Assumes overall responsibility for the execution, reporting and evaluation of clinical trials as well as assures conduct of the trials in compliance with applicable requirements including but not limited to GCP🎯Manage clinical trials according to plan and in compliance with applicable laws, regulations, and guidelines (ICH, EMA, FDA, and others). 🎯Participate in the selection of CROs and other external vendors and control the execution of all contracted activities and ensure that the activities are conducted in accordance with the requirements (cost, quality, and time).🎯Review the necessary documentation before (e.g. Protocol, ICF, etc.), during (e.g. Monitoring etc.) and at the end (e.g. Study Report, etc.) of clinical trials.🎯Works effectively within multidisciplinary teams, including sponsor team, Contract Research Organizations (CROs), and site staff.🎯Prepare detailed monitoring visit reports (MVRs) and other documentation accurately and professionally.🎯Perform source data verification (SDV), ensuring data accuracy and completeness.🎯Train site staff on trial protocols, safety reporting, and GCP compliance.🎯Monitors IP handling, storage, and accountability at trial sites.🎯Anticipates potential trial risks and implements corrective and preventive actions (CAPA).🎯Coordinate internal Chemo activities and procedures related with the conduct of the clinical trials (e.g. investigational medication shipment, etc.).🎯Collaborate with other departments and experts (e.g. in Pharmaceutical Development, Regulatory, Pharmacovigilance, Project Management) to define strategies and plans for projects execution and execute clinical activities according to agreed plans. 🎯Participate in the maintenance of GCP system through elaboration and/or review of applicable SOPs, etc.What do you need?💊Mandatory: University degree in Life Science discipline💊Desired: Experience with trials in multiple therapeutic areas (e.g., oncology, cardiology, neurology).💊Fluent in English required, communicative level in Spanish is a plus, knowledge of other languages will be an asset.💊Willingness to travel (10%).Our benefits! ⏰Full day schedule with half an hour for lunch.📜Indefinite contract.💸Attractive salary package.🥼 Life and accident insurance.🥼 Co-payment on voluntary health insurance.🥼 Nursing service.💸Benefits and Savings Club.🎾Company sports activities.🍉Fruit day.🅿️Párking company.🍼Kindergarten voucher and school aid.🏆Seniority recognition.📈Development plans, internal mobility policy.⭐Many more!