Sr. Clinical Research Associate
Dendreon Pharmaceuticals LLCAbout the role
<div class="content-intro"><p><strong><u>WHO WE ARE</u></strong><strong>:</strong> </p> <p>At Dendreon, we’re transforming the battle against cancer with personalized immunotherapy. Our flagship product, <strong>PROVENGE® (sipuleucel-T)</strong>, was the first FDA-approved immunotherapy for metastatic castrate-resistant prostate cancer, utilizing a patient’s own immune cells to fight the disease. </p> <p>If you’re driven by the opportunity to make a meaningful impact on cancer patients’ lives, we invite you to join our team. With Immunotherapy Manufacturing Facilities in Seal Beach, CA, and Union City, GA, a talented team of scientific, clinical, regulatory, and corporate professionals based in Seal Beach, and a commercial organization operating across the United States, Dendreon continues to advance innovation in personalized cancer treatment.</p> <p><strong><u>CORE VALUES:</u></strong></p> <ul> <li><strong>Put Patients First: </strong>Every day is an opportunity to improve the lives of those living with cancer.</li> <li><strong>Act with Integrity: </strong>We commit to transparency, honesty, and always doing what’s right.</li> <li><strong>Build Trust: </strong>Trust is earned through candid, open communication and a collaborative approach.</li> <li><strong>Raise the Bar: </strong>We embrace continuous improvement and innovation, always striving to elevate our people.</li> <li><strong>Drive Results: </strong>We are accountable to each other and deliver success together.</li> </ul></div><p><strong><u>JOB SUMMARY:</u></strong> 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</p> <p><strong><span style="text-decoration: underline;">NOTE</span>: This role requires on-site presence at our Seal Beach, CA location.</strong></p> <p><strong><span style="text-decoration: underline;">Responsibilities:</span></strong></p> <ul> <li>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
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