Senior CRA: On-Site Oncology Trials Lead

Dendreon Pharmaceuticals; Seal Beach (CA); On-site; USD 90,000 - 117,000; Full time

Job summary

Dendreon Pharmaceuticals seeks a Sr. Clinical Research Associate to lead monitoring of oncology trials from Seal Beach, CA. This on-site role requires collaboration with investigators, vendors and internal teams, ensuring adherence to protocols and regulatory standards.

You will manage site initiation, monitoring, and close-out activities, develop trackers, and support study forecasting and audits. Applicants should have 5–8 years in clinical trials, 3–5 years independent monitoring, and strong

Qualifications

• Bachelor’s degree in a scientific discipline or healthcare-related field.
• 5–8 years of clinical trial experience, multi-site management.
• Minimum 3–5 years of independent monitoring experience.
• Strong knowledge of GCP/ICH and regulatory requirements.
• Experience with EDC, CTMS, EDMS and office tools.

Responsibilities

• Site monitoring and management: remote and on-site visits; RBM familiarity; IP accountability.
• Primary contact for investigators, study coordinators, vendors, and internal stakeholders.
• Lead CRA or regional lead CRA when assigned.
• Coordinate site start-up, monitoring, and close-out activities with regulatory document review.
• Provide guidance on protocol implementation and regulatory requirements.
• Develop and maintain study trackers, dashboards, and risk tools.
• Track milestones, enrollment, and activation timelines.
• Travel to sites up to ~75% as required.

Skills

GCP/ICH

Monitoring

EDC

CTMS

Communication

MS Office

Regulatory knowledge

Education

Bachelor's degree

Tools

EDMS

Smartsheets

Job description

Dendreon Pharmaceuticals seeks a Sr. Clinical Research Associate to lead monitoring of oncology trials from Seal Beach, CA. This on-site role requires collaboration with investigators, vendors and internal teams, ensuring adherence to protocols and regulatory standards.

You will manage site initiation, monitoring, and close-out activities, develop trackers, and support study forecasting and audits. Applicants should have 5–8 years in clinical trials, 3–5 years independent monitoring, and strong