Hybrid – Madrid) 3 days office-based (MUST) + 2 days (home-based) Location : Madrid, Spain (Hybrid) About the Role We are currently seeking an In-house Clinical Research Associate II to join our client's Global Clinical Operations (GCO) Center of Excellence in Madrid. You will play a critical role in supporting site start-up and clinical trial operations across international studies. This hybrid position offers the opportunity to work in a high-performing, collaborative, and innovative environment, where you'll engage with cross-functional teams to support the execution of high-quality, patient-focused clinical research. Key Responsibilities Coordinate Ethics Committee (EC) submissions and approvals. Manage Informed Consent Form (ICF) customization and negotiation with sites. Collect and track essential regulatory documents across multiple studies. Partner with regulatory teams for Competent Authority (CA) submissions. Support site start-up timelines, tracking investigator readiness and compliance. Update systems (CTMS, eTMF) with accurate site-level data and documentation. Provide regular updates to clinical leadership on progress, risks, and approvals. Support enrollment, site communications, audits, and study close-out activities. Ensure compliance with ICH / GCP, MDR, GDPR, and internal SOPs. What We're Looking For Minimum Requirements : Bachelor's degree in life sciences or related field. Prior experience with EC submissions in Spain. Fluency in English and Spanish (written & spoken); third language is a plus. Strong organizational and communication skills. Ability to multitask and work proactively in a fast-paced environment. Comfortable engaging with sites via phone and email. Preferred : Previous experience as In-house CRA, Study Start-up Specialist, or Regulatory Specialist, Clinical Research Coordinator. Experience working with CTMS / eTMF systems (e.G., Siebel CTMS, Veeva). Experience with EC submissions outside of Spain is a plus. Why Join Us? Contribute to cutting-edge clinical trials in a global environment. Work with a highly supportive and mission-driven team. Hybrid work model offering flexibility and autonomy. Long-term opportunities for professional growth within Oxford General Resources Consulting firm +40 years experience in Life Sciences. Interested? Apply directly through LinkedIn or share your CV with us at We look forward to hearing from you #J-18808-Ljbffr