Onsite Senior CRA Lead, Multi-Site Oncology Trials

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

Job summary

Dendreon in Seal Beach, CA, is seeking a Sr. Clinical Research Associate to ensure compliant and timely conduct of multi-site clinical trials, with on-site presence required.

You will monitor sites, manage regulatory documents, and collaborate with investigators and internal stakeholders to drive trial quality and timelines. The role requires 5–8 years of trial experience, independent monitoring expertise, and strong knowledge of GCP and ICH guidelines.

Qualifications

• Bachelor’s degree in a scientific discipline or healthcare-related field.
• 5–8 years of clinical trial experience with multi-site management.
• Minimum 3–5 years of independent monitoring experience.
• Strong working knowledge of GCP/ICH and regulatory requirements.
• Experience with site initiation, monitoring, and close-out activities; SAE reporting knowledge.

Responsibilities

• Conduct remote and on-site monitoring visits, RBM familiarity, source data verification, and IP accountability.
• Serve as primary contact for investigators, study coordinators, and internal stakeholders.
• Lead CRA activities as study lead or regional lead CRA when assigned.
• Coordinate site start-up, monitoring, and close-out activities; maintain study files.
• Provide guidance on protocol implementation and regulatory requirements; support study start-up and monitoring strategies.
• Track milestones, enrollment, and site activation; develop and maintain trackers and dashboards.
• Prepare training materials to ensure compliant study execution.
• Travel to clinical trial sites up to ~75% as required.

Skills

GCP/ICH knowledge

Site monitoring

Regulatory documentation

Communication

Cross-functional collaboration

Education

Bachelor's degree in a scientific field

Tools

EDC

CTMS

EDMS

MS Office

Job description

Dendreon in Seal Beach, CA, is seeking a Sr. Clinical Research Associate to ensure compliant and timely conduct of multi-site clinical trials, with on-site presence required.

You will monitor sites, manage regulatory documents, and collaborate with investigators and internal stakeholders to drive trial quality and timelines. The role requires 5–8 years of trial experience, independent monitoring expertise, and strong knowledge of GCP and ICH guidelines.