In-House Clinical Research Associate I/II – Spanish, English, Portuguese

• Support site management activities throughout the study lifecycle, including feasibility, study initiation, interim and remote monitoring, and close-out activities
• Maintain regular communication with assigned sites and partner with Clinical Trial Managers and field CRAs
• Review site documentation for quality and completeness
• Support Trial Master File (TMF) filing and reconciliation and help maintain Investigator Site Files (ISFs)
• Review electronic data capture (EDC) records and assist sites with resolving data management and vendor queries
• Prepare CRAs for site visits by tracking and communicating action items, protocol deviations, outstanding queries, study supplies, training, and other open activities
• Coordinate study materials, support site staff changes and system access, and help keep training, qualifications, delegation, and regulatory documentation current
• Support site prescreening, screening, recruitment, and Subject Eligibility Review tracking
• Maintain study trackers, retrieve information from study-specific portals and systems, and provide timely updates to Clinical Trial Managers and project teams
• Serve as a key operational contact for clinical research activities when appropriate

• Four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or another related science is preferred
• Alternatively, a two-year college curriculum or equivalent education/training plus at least one year of relevant clinical research experience may be considered
• Alternatively, other relevant education/training plus at least two years of clinical research experience may be considered
• Basic understanding of clinical research principles and processes
• Knowledge of applicable FDA and/or EU regulations, ICH Guidelines, local regulatory requirements, and standard operating procedures
• Strong written and verbal communication skills
• Planning, organization, and time-management skills
• Basic knowledge of Microsoft Office
• Familiarity with IVRS and electronic CRF systems
• Proficiency in spoken and written English, Spanish, and Portuguese
• Fluency in the local languages of the countries under your responsibility

• Collaborative and inclusive work environment
• Growth and learning opportunities
• Opportunity to contribute to meaningful clinical research improving patients' lives
• Remote work arrangement