Senior Clinical Research Associate Job in South San Francisco 94080, California US
Onyx Pharmaceuticals is hiring! We have an immediate opening for a Senior Clinical Research Associate in our growing South San Francisco office! This is an exciting opportunity for someone currently in the role of any one of the following: Clinical Trial Manager, Sr. CRA, CRA II, Clinical Project Manager, or Manager of Clinical Operations.
Key responsibilities include but are not limited to the following:
- Implement, oversee, and manage clinical studies, ensuring the quality and integrity of data and compliance with FDA, ICH/GCP guidelines
- Manage budgets, schedules and oversee vendors such as CROs, data management, etc.
- Prepare and conduct study initiation, closeout and monitoring visits at clinical investigative sites to ensure adherence to procedures, protocols and project plans in accordance with FDA regulations
- Maintain site files, trial master files and study documentation.
- Mentor junior CRAs and staff
- Oversee clinical operations and interface with senior management/executive staff
Qualified candidates must have a minimum of 5 years of recent experience as a CRA II, Sr. CRA, Clinical Project Manager, Clinical Trials Manager, Manager of Clinical Operations, or similar role. Experience managing studies domestically, international experience highly desired. Candidates should also have experience in multiple, complex therapeutic areas including oncology. Bachelor's degree in a scientific discipline is highly preferred.
Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of people with cancer. The company, in collaboration with Bayer HealthCare Pharmaceuticals Inc., is developing and marketing Nexavar® (sorafenib) tablets, a small molecule drug that is currently approved for the treatment of liver cancer and advanced kidney cancer. Additionally, Nexavar is being investigated in several ongoing trials in a variety of tumor types. Beyond Nexavar, Onyx has established a development pipeline of anticancer compounds at various stages of clinical testing, including carfilzomib, a selective proteasome inhibitor, that is currently being evaluated in multiple clinical trials for the treatment of patients with relapsed or relapsed/refractory multiple myeloma and solid tumors. ONX 0801, an alpha-folate receptor targeted inhibitor of thymidylate synthase, and ONX 0912, an oral proteasome inhibitor, are currently in Phase 1 testing. For more information about Onyx, visit the company's website at www.onyx-pharm.com .