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Senior Clinical Research Assistant I
IQVIA
Sponsorship not confirmed
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About the job
IQVIA · Barcelona At IQVIA, our Clinical Functional Service Partnership (CFSP) model gives you the best of both worlds: the variety and sponsor-level exposure of working as an embedded member of a leading pharmaceutical or biotechnology team, backed by the stability, global infrastructure, and career support of IQVIA. You'll develop deep, specialist expertise on a dedicated program, with the flexibility to expand across sponsors and therapeutic areas as your career progresses - and the security of a long-term IQVIA career even as individual programs evolve. Through our long-standing partnerships with the world's leading pharmaceutical and biotechnology companies, you'll contribute to clinical research programs that bring innovative treatments to patients worldwide, working across all phases of development and a broad range of therapeutic areas, within a culture that supports flexibility, continuous learning, and wellbeing. Key Responsibilities: Conduct site qualification, initiation, monitoring, and close-out visits in accordance with study protocols, GCP, ICH guidelines, and applicable regulatory requirements. Ensure investigational sites maintain high standards of patient safety, data integrity, protocol compliance, and study quality. Build and maintain effective relationships with investigators and site personnel, providing ongoing guidance, training, and support throughout the study lifecycle. Monitor study progress, including regulatory documentation, patient recruitment and enrollment, data query resolution, and site performance metrics. Collaborate with sites to implement and optimize patient recruitment and retention strategies to support study timelines. Maintain accurate, complete, and inspection-ready study documentation, including Investigator Site Files (ISF), Trial Master Files (TMF), monitoring reports, and follow-up communications. Identify, assess, and appropriately escalate study risks, site issues, and quality concerns while driving timely resolution. Partner closely with cross-functional study teams to support successful study execution and delivery of project objectives. Mentor and support junior clinical team members through coaching, training, and co-monitoring activities, as applicable. Contribute to continuous improvement initiatives and support study start-up, maintenance, close-out, and site financial activities as required. What you'll bring: University degree in Life Sciences, Health Sciences, Nursing, Pharmacy, or a related discipline, or equivalent combination of education and experience. 3-5 years on-site monitoring experience of clinical trials within a CRO, pharmaceutical, biotechnology, or healthcare environment. Strong knowledge of GCP, ICH guidelines, and applicable regulatory requirements. Preferable experience in a sponsor-dedicated or cFSP environment. Knowledge of patient recruitment and study start-up activities is preferred. Excellent communication, organizational, and stakeholder management skills. Fluent written and verbal communication skills in local language (minimum C1 level), along with a strong command of English. Ability to work independently, manage multiple priorities, and collaborate effectively within cross-functional teams. Willingness to travel within the assigned region (up to 40-60% of working time). A valid Class B driver's license.
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