Clinical Research Associate I/II/Sr.

Summary Of The Role Responsible for site management and monitoring of clinical studies in compliance with SOPs, ICH GCP guidelines, and regulatory requirements.Conducts various monitoring visits including Pre-study, Site Initiation, Routine, and Close-out, ensuring data integrity and subject protection.Prepares project plans, verifies regulatory documents, manages investigational product inventory, and ensures audit readiness.Acts as a Lead CRA when assigned and supports site staff training, investigator recruitment, and site management activities.Ensures adherence to protocol, informed consent, and regulatory procedures; reviews source documents; manages data review and query resolution.Tracks adverse events, manages trial documentation, and maintains clinical trial management systems and eClinical tools.Qualifications include a degree or health profession certification, with a minimum of 1.5 years of monitoring experience for external candidates and 1 year for internal candidates.Skills required include understanding of GCP, monitoring procedures, and clinical trial processes; proficiency in English and local language; strong organizational and communication skills.Preferred qualifications include Phase I experience, life sciences background, additional years of related experience, and knowledge of regulatory standards.Work involves computer use, site visits, and travel; physical demands include prolonged sitting, handling objects, and potential outside hours.