Sr. Clinical Research Associate

Role: Senior Clinical Research Associate responsible for site monitoring and trial management in Xencor's clinical programs, primarily focusing on ensuring compliance with GCP, ICH guidelines, and SOPs across multiple studies. Responsibilities include document management in electronic TMF, site initiation and monitoring visits, oversight of subject recruitment and data integrity, and collaboration with CROs, vendors, and study sites. The position also involves developing regulatory documentation, managing trial supplies, tracking trial progress, and supporting study budgets. It includes mentorship duties and participation in investigator meetings and training. Qualifications: High school diploma with 9+ years or Bachelor’s with 5+ years of relevant experience; at least 3 years of clinical site management and vendor oversight, preferably within biotech or pharma. Skills required include strong organizational ability, knowledge of clinical trials (Phase I-III), GCP, and proficiency with systems like Veeva Vault and SmartSheet. Experience with AI tools, team management, and familiarity with small molecule or biologic development is preferred. The role entails occasional travel between Pasadena and San Diego offices, full-time work onsite, and offers a competitive salary range. High-value biopharma specifics include involvement in early to late-phase clinical trials for cancer therapies, with a focus on compliance, documentation, and stakeholder collaboration.