SENIOR CLINICAL RESEARCH ASSOCIATE - SPAIN

A new opportunity for an enthusiastic, motivated and experienced Senior Clinical Research Associate in Spain to join our George Clinical team! We are a team that works for each others success and you will love being a part of our staff!Who are we?A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence20+ years of experience, ~500 people managing 39+ geographical locations throughout the Asia-Pacific region, USA, and EuropeFull range of clinical trial services to biopharmaceutical, medical device, and diagnostic customers, for all trial phases, registration and post-marketing trialWe combine scientific leadership and global operational excellence, with strong experience in renal medicine, oncology, cardiovascular and chronic diseases across various phases to improve the health of millions worldwide.Why work with us?We are a global team making a difference in the world – our clinical trials improve the health of millions worldwideCompetitive salary and benefitsFlexible and agile working arrangements - onsite, hybrid or WFH (dependent on location)Strong and diverse Learning & Development opportunities including exposure to all aspects of clinical trials with an unparalleled network of Scientific Leaders to learn fromA focus on employee well being including global employee engagement surveys, steps challenges, reward and recognition programs, team building activities and other fun events!What does the role involve?Coordinating the identification, feasibility assessment and selection of investigators and sitesPreparing, organizing, conducting and following-up site evaluation visits, site initiation visits, routine monitoring and close out visits as per relevant study planMotivating and training investigators and site staff to ensure obligations in regards to study timelinesEnsuring ethics submissions are made by investigator sites in a timely mannerAdhering to ICH-GCP and any other regulatory guidelines and requirements including adverse events and serious adverse event reportingVerifying the quality, accuracy, completion and timeliness of dataCompletely and efficiently resolving data and audits queries and issuesAdhering to the study protocol and study procedures manualCompliance with mandatory SOPs as agreed for the studyCompleting all reports accurately and within the predetermined timelinesMaintain study information using the clinical trial management system.What are our expectations of candidates?Bachelor degree in a science or related field and seven+ years related experience; OR ten years related experience and/or training in a clinical setting, science related field, or clinical research experience; OR equivalent combination of education and experience. Relevant work experience should include at least seven (7) years of Monitoring experience Phase I oncology monitoring experience requiredExcellent working knowledge of ICH/GCP, ethical and regulatory requirementsExcellent interpersonal skills, presentation skills and the ability to work well and autonomously, in small teams and with a wide range of varying stakeholdersExcellent organisational skills – ability to organise, take initiative and follow-up independentlyFamiliarity with computer systems particularly MS office, electronic data capture and project management systemsAbility to see the big picture, yet still focus on detail and quality workAbility and willingness to travel (up to 80%)Tertiary qualifications in a related science or health-care disciplineRegulatory experience across multiple EU countries and experience in cross country monitoring (multilingual) advantageous. You must be willing to extend yourself and take on new challenges while living our values of Mutuality, Integrity, Can-do approach, Empowerment and Excellence alongside your colleagues globally - we keep each other in check and work better together!To apply, please send your queries or CV to careers@georgeclinical.com as soon as possible or let us know if you would like to have a confidential discussion about these opportunities. Follow us on Linkedin to learn more about your future with George Clinical.We are reviewing applications as we receive them but please note that only short-listed applicants will be contacted.