Senior Clinical Research Associate
Clinical Operations | South San Francisco, CA, United States

The Senior Clinical Research Associate (Sr. CRA), Clinical Operations, will coordinate the activities associated with the evaluation, initiation, management, and close-out of clinical trials within the Clinical Operations Department. The Senior CRA 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. 

Clinical Trial Management Responsibilities:
  • Identify, select, and monitor 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 review or approval of IP release packages
  • Negotiate and manage the budget and payments for investigative sites, if applicable
  • Write or contribute to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
  • Clinical data review of data listings and summary tables, including query generation  
  • Oversee performance of 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
  • Other duties as assigned
Departmental and Line Management Responsibilities:
  • Assist in the development of department or cross functional SOPs
  • Collaborate with CRAs and Directors to identify Clinical Operations’ process needs
  • Interact with internal work groups to evaluate departmental needs, resources and timelines
 Management of Direct Reports (if applicable):
  • Mentor, train, and supervise staff at a functional level
  • Ensure each new direct report is on-boarded and trained per Onyx and departmental guidelines and SOPs, if applicable
  • Review and authorize activities to assess the workload of direct reports
  • Identify any performance issues and ensure an appropriate and timely performance improvement plan is undertaken
  • Identify training needs for direct reports and develop training plans to address those needs