Senior Clinical Research Associate (Barcelona)

Senior Clinical Research Associate (Barcelona)

28 oct
|
Worldwide Clinical Trials
|
Barcelona

28 oct

Worldwide Clinical Trials

Barcelona

Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research. Make an Impact as a Senior Clinical Research Associate at Worldwide As a Senior Clinical Research Associate, you'll play a key role in protecting patient safety, maintaining high-quality clinical data, and ensuring investigative sites deliver studies in line with Good Clinical Practice (GCP), regulatory requirements, protocols, and SOPs. You'll take ownership of the full site monitoring lifecycle, from qualification and initiation through interim monitoring, site management, and close-out. You'll work closely with sites and study teams to strengthen protocol adherence, resolve data queries, maintain essential documentation, and ensure safety information is appropriately reviewed and reported. You'll also have the opportunity to bring your experience beyond individual sites, acting as a Lead CRA on global studies, coordinating and mentoring CRAs, contributing to monitoring plans, reviewing visit reports, delivering training, and supporting study milestones. This is a home-based Clinical Research Associate role supporting sites across Spain. You will collaborate with sites, sponsors, and global study teams while traveling to investigative sites approximately 8-10 days per month. Lead site qualification, initiation, interim monitoring, management, and close-out activities, ensuring compliance with protocols, GCP, applicable regulations, and SOPs. Protect patient safety and data integrity by reviewing informed consent and safety information, conducting source document verification, reviewing CRFs, and supporting timely query resolution. Coordinate CRAs as a Lead CRA on integral studies and provide mentoring, training, accompanied visits, and practical guidance to less experienced colleagues and site staff. Partner with Project Management and study teams to evaluate deliverables, study milestones, site performance, and monitoring activities. Develop monitoring plans, study-specific tools, templates, and training materials as requested to support consistent study delivery. Contribute your clinical monitoring expertise to study team and investigator meetings, bid defenses, and the design of protocols and CRFs. Education and CRA

experience:
an MD or Pharmacy qualification (MSPH, PharmD, PhD, equivalent Pharmacy degree, or similar) with at least 3 years' CRA experience; or a minimum four-year college curriculum in medical, biological, physical, health, pharmacy, or another related science with at least 5 years' CRA experience; or a two-year college curriculum or equivalent education/training, preferably a nursing or equivalent life science degree, with at least 7 years' CRA experience. Extensive knowledge of clinical research principles and processes, with a thorough understanding of FDA and/or EU regulations and directives, ICH Guidelines, local regulatory requirements, and SOPs. Excellent communication, interpersonal, planning, organizational, time-management, initiative, and problem-solving skills, alongside the ability to lead and motivate an assigned team when applicable. Technical proficiency with Microsoft Office, IxRS, and electronic data capture (EDC) systems. Experience in full-service monitoring PREFERRED. Proficiency in spoken and written English, together with fluency in the local languages of the countries under responsibility. Discover the Difference at Worldwide Clinical Trials.

📌 Senior Clinical Research Associate (Barcelona)
🏢 Worldwide Clinical Trials
📍 Barcelona

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