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Clinical Research Associate 2

Onyx Pharmaceuticals, Inc.

South San Francisco, CA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Based in South San Francisco, California, Onyx Pharmaceuticals is an Amgen subsidiary, engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer.  At Onyx, our success begins with our employees. The progress we have made as a company reflects the talents of the individuals who have come together to develop possible new therapeutics for treating cancer.

Onyx is seeking talented and dedicated individuals of the highest caliber who are passionate about the pharmaceutical industry and driven to change the way cancer is treated.  We are proud to be an equal opportunity employer who respects individual differences and recognizes each employee as an integral member of our company.  Our culture is one where everyone can learn and develop personally and professionally.
The Clinical Research Associate II (CRA II), Clinical Operations, will participate in the activities associated with the evaluation, initiation, management, and close-out of clinical trials within the Clinical Operations Department. The CRA II role provides an outstanding opportunity to work in a cross-functional environment and collaborate with colleagues in Clinical Science, Biometrics, Regulatory & QA, Drug Safety, Medical Writing, and Program Management. Responsibilities are dependent upon the type and timing of the program to which the CRA II is assigned.

* Assist with the identification, selection and monitoring of investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits
* Develop and maintain good working relationships with investigators and study staff, serving as an ambassador to promote Onyx’s high quality and ethical standards
* Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
* Track progress of study including patient enrollment, monitoring visits
* Review key study quality metrics (e.g., eligibility, tumor assessments, primary endpoint data, etc.) and follow-up with the SET to determine appropriate action
* Investigate queries, monitor discrepancies
* Manage investigational product (IP) accountability and reconciliation process
* Responsible for the review of IP release packages
* Ensures that all essential clinical documents and business documents are in place for assigned sites to ensure timely site initiation and subject/patient enrollment
* Assist with the negotiation and management of the budget and payments for investigative sites, if applicable
* Contribute to the preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
* Maintains all essential clinical documents and business throughout the assigned clinical study (ies)
* Assist with clinical data review of data listings and summary tables, including query generation
* Partner with CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to manager or CRO as appropriate
* Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work
* Assist with CRA training on protocols and practices consistent with Onyx and GCP standards
* Assist in identification and hiring of appropriate CROs and third party study vendors in accordance with Onyx SOP
* Assists with preparing for meetings such as investigator meetings, partner meetings, scientific meetings, etc. as requested
* Other duties as assigned
Departmental Responsibilities:
* Review and assist in the writing or revision of department or cross functional SOPs
* Collaborate with department members to identify Clinical Operations’ process needs
* Interact with internal work groups to evaluate departmental needs, resources and timelines

* Bachelor’s degree
* 3 years of clinical research monitoring experience

* Bachelor’s degree in a scientific discipline
* Sponsor experience
* Oncology experience
* Good computer skills (MS Office)
* Strong working knowledge of FDA & ICH/GCP regulations and guidelines
* Thorough knowledge of clinical monitoring procedures
* Good analytical and assessment skills
* Good judgment and problem solving skills

Amgen is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.


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