Senior Clinical Research Associate

hace 6 días

Madrid, Madrid, España Sin Nombre A tiempo completo
About the Role

Sin Nombre is seeking a highly skilled and experienced Senior Clinical Research Associate to join our Clinical Development team. As a key member of our team, you will be responsible for ensuring the successful execution of clinical trials, from site activation to close-out.

Key Responsibilities
  • Act as the primary point of contact with assigned sites, ensuring quality and delivery during the start-up phase.
  • Build and maintain strong relationships with investigators and site staff, fostering a collaborative environment.
  • Conduct feasibility and site qualification activities, including preparation, negotiation, and facilitation of Confidentiality Agreements (CDAs).
  • Generate high-quality visit/contact reports, identifying site issues and implementing problem-solving strategies to direct resolution.
  • Develop and implement strategies for configuring, distributing, collecting, reviewing, and approving country-specific and site-specific documents, including regulatory documentation.
  • Customize, review, and negotiate Informed Consent Forms (ICFs), translations, and amendments, ensuring compliance with regulatory requirements.
  • Submit all pertinent documentation to the trial master file, adhering to project plans, sponsor, and company policies.
  • Forecast, develop, manage, and revise plans and strategies for IRB/IEC and MoH/RA submission/approval, site activation, and CTMS updates.
  • Promptly identify, address, and resolve or escalate any site questions and/or issues, utilizing judgment and knowledge.
Requirements
  • Proven experience as a Clinical Research Associate in the biotech and pharmaceutical industry.
  • Strong understanding of clinical trial regulations, including GCP, ICH, and local regulations.
  • Excellent communication, negotiation, and problem-solving skills.
  • Ability to work independently and collaboratively as part of a global team.
  • Proficiency in Clinical Trial Management systems (CTMS) and other relevant software.
About Sin Nombre

Sin Nombre is a leading provider of clinical research services, dedicated to delivering high-quality solutions to the biotech and pharmaceutical industry. Our team of experts is passionate about advancing medical research and improving patient outcomes.

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