Sr. Clinical Research Associate

Xencor; San Diego (CA); In loco; USD 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

Scorpion Therapeutics seeks a Senior Clinical Research Associate to oversee site monitoring and trial management for oncology programs, ensuring GCP/ICH compliance and robust data integrity. The role requires coordination with CROs and study sites and active TMF management.

This full-time, onsite position may involve travel between Pasadena and San Diego offices and offers a competitive salary and benefits.

Competenze

• High school diploma with 9+ years or Bachelor's with 5+ years of relevant experience; at least 3 years of site management and vendor oversight.

Mansioni

• Document management in electronic TMF, site initiation and monitoring visits, oversight of recruitment and data integrity; collaboration with CROs, vendors, and study sites.
• Develop regulatory documentation, manage trial supplies, track trial progress, and support study budgets.
• Mentorship duties and participation in investigator meetings and training.

Conoscenze

Organizational skills

GCP knowledge

Clinical trials

AI tools

Team management

Strumenti

Veeva Vault

SmartSheet

Descrizione del lavoro

Senior 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

• 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.
• developing regulatory documentation, managing trial supplies, tracking trial progress, and supporting study budgets.
• 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.

Required Skills and Experience

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.