Job Details

Role:Clinical Research Associate
Location:San Francisco, CA

Essential Job Functions:
Performs general administrative functions such as clinical trial tracking, providing logistical support to one or more of the Clinical Development management teams, tracking and managing distribution of non-clinical supplies throughout the course of the studyTracks and maintains study information and reports on study progressOversees IRB/IEC submission document collection and other supplementary documentation as appropriateTMF

Management:

• Oversees and ensures the completeness of the Study Level Trial Master File (TMF) in accordance with SOP requirements and in collaboration with the Clinical Trial AssociateServes as key central contact for communications, correspondence and associated documentation.
• Performs duties such as, clinical form design, and filing of correspondence, lab reports, clinical monitoring reports, and other study documentsMaintains and ensures all documentation is in a state of audit-readiness.
• Maintains accurate tracking and reporting of study management dataCoordinates study logistics, documents, drug shipments, enrollment and safetyPerforms all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, and appropriate industry and Good Clinical Practices standards.
• Supports other projects as assignedCoordinates Investigator and Study Coordinator meetings in collaboration with the Clinical Trial Manager and Clinical Trial AssociatePerforms data entry into designated clinical tracking systems in accordance with project requirements, including collection of information from designated clinical team members, CROs, vendors, etc.
• Coordinates communication for defined tasks and tracking information between the study team and vendorIdentifies and contributes to areas of best practice and process improvementKnowledge, Skills, And Experience
  

• A Bachelor degree is requiredSelf-starter with ability to travel and work independently with limited oversight.
• Must have recent oncology or immunoncology experience4+ years of experience, in clinical research/drug developmentFamiliar with concepts of clinical research and able to work effectively in a team environmentKnowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required.
• Ability to deal with time demands, incomplete information or unexpected events.
• Must possess excellent Word, Excel skillsMust have the strong ability to build and maintain positive relationships with management, peers and site partners.
• Excellent written and verbal skills requiredSolid organizational skills including attention to detail and multi-tasking skills.