Sr. Clinical Research Associate

Sr. Clinical Research Associate

The Sr. Clinical Research Associate is accountable for the compliant and timely conduct of clinical trials. This role ensures adherence to protocols, regulatory standards, and applicable guidelines while maintaining high-quality outcomes and fostering effective collaboration with site staff and internal Dendreon stakeholders.

This role requires on-site presence at our Seal Beach, CA location.

Responsibilities

• Site Monitoring & Management: Conduct remote and on-site visits (site assessment, initiation, routine monitoring, and close-out); Familiar with Risk Based Monitoring (RBM), verify source data, ensure ongoing subject safety review, and audit IP accountability per the monitoring plan. Familiar with CAPA. prepares timely, accurate, and comprehensive monitoring visit reports.
• Serve as the primary point of contact for investigators, study coordinators, vendors, and internal stakeholders, fostering effective communication and collaboration throughout the trial lifecycle.
• Serve as a study lead CRA or regional lead CRA when assigned.
• Coordinate site start-up, ongoing monitoring, and close-out activities, including regulatory document review and maintenance of study files.
• Provide guidance and support to clinical sites on protocol implementation, regulatory requirements, and issue resolution.
• Support study start-up and development activities, including review of protocols, Case Report Forms, and Informed Consent Forms, and contribution to monitoring strategies and investigator meetings.
• Track study milestones, enrollment progress, and site activation timelines.
• Develop and maintain study trackers, dashboards, and risk management tools.
• Lead site performance reviews and identify sites requiring additional support or escalation.
• Assist in the development, review, and maintenance of study documentation, including protocols, SOPs, training materials, and other essential trial documents.
• Develop and deliver study-related training in alignment with company policies and SOPs to support consistent and compliant study execution.
• Maintain systems and processes to track trial progress, report study status, and ensure clinical trials are conducted on time, within budget, and in compliance with regulatory standards.
• Participate in ongoing clinical training and stay current on developments in clinical research and regulatory guidance.
• Work independently while collaborating effectively within cross-functional teams; contribute to broader study management and process improvement initiatives as appropriate based on experience level.
• Perform additional responsibilities as assigned.
• Travel to clinical trial sites up to approximately 50% as required.
• Support study forecasting, resource planning, and issue management.
• Assist with inspection readiness activities and sponsor audits.

Qualifications

• Education: Bachelor's degree in a scientific discipline or healthcare-related field.
• Experience: 5-8 years of clinical trial experience, including multi-site study management.
• Minimum 3–5 years of independent monitoring experience.
• Technical Knowledge: Strong working knowledge of Good Clinical Practice (GCP) research standards, ICH guidelines, and applicable regulatory requirements.
• Monitoring Skills: Intermediate to advanced clinical monitoring experience, including site initiation, routine monitoring, and close-out activities. Comprehensive understanding of Serious Adverse Event (SAE) reporting and follow-up requirements.
• Systems Proficiency: Proficiency with clinical research systems, including Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS), Microsoft Office applications (Excel, Word, PowerPoint, etc), Smartsheets.
• Communication: Strong written and verbal communication skills with the ability to interact professionally and effectively with internal teams, investigators, and external partners.

Preferred Experience

• Experience across the full drug development lifecycle.
• Experience working in Oncology, Immunology.
• Therapeutic area and protocol knowledge gained through prior experience or company-provided training.
• Experience in both CRO and sponsor environments preferred.
• Experience leading study teams or acting as Lead CRA strongly preferred.

Working Conditions and Physical Requirements:

• Ability to sit or stand for extended periods of time.
• Finger dexterity is sufficient to use a computer and to complete paperwork activities.
• Vision sufficient to use a computer, to read written materials and to complete paperwork activities.
• Ability to work across multiple time zones when necessary.
• Hearing sufficiently to communicate with individuals virtually and in person.
• Ability to lift up to 25 pounds.
• Incidental exposure to temperature-controlled areas (e.g during IP accountability verification).