Clinical Research Associate
Clinical Development | San Francisco, Ca | Full Time
Overview of the Role
The CRA is responsible for providing support to the Clinical Development management team, clinical tracking and document maintenance as applicable to study vendors and clinical trial sites. This position will work closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets.
Reporting Structure and Team
The CRA reports to the Sr. Director of Clinical Operations and is a key member of the Clinical Development team.
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 study
- Tracks and maintains study information and reports on study progress
- Oversees IRB/IEC submission document collection and other supplementary documentation as appropriate
- TMF 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 Associate
- Serves 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 documents
- Maintains and ensures all documentation is in a state of audit-readiness
- Maintains accurate tracking and reporting of study management data
- Coordinates study logistics, documents, drug shipments, enrollment and safety
- Performs 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 assigned
- Coordinates Investigator and Study Coordinator meetings in collaboration with the Clinical Trial Manager and Clinical Trial Associate
- Performs 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 vendor
- Identifies and contributes to areas of best practice and process improvement
Knowledge, Skills, and Experience
- A Bachelor degree is required
- Self-starter with ability to travel and work independently with limited oversight
- Must have recent oncology or immunoncology experience
- 4+ years of experience, in clinical research/drug development
- Familiar with concepts of clinical research and able to work effectively in a team environment
- Knowledgeable 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 skills
- Must have the strong ability to build and maintain positive relationships with management, peers and site partners
- Excellent written and verbal skills required
- Solid organizational skills including attention to detail and multi-tasking skills.
Introduction to the Organization
The Parker Institute for Cancer Immunotherapy (“PICI” or the “Parker Institute”) is a not-for-profit organization whose mission is to accelerate the development of immunological cures for cancer through innovative science, advanced technologies and new modes of research collaboration. The Institute is based in San Francisco, California and officially launched in April 2016.
To achieve its mission, PICI has established significant new cancer immunology research centers at six of the top cancer research and treatment institutions in the country (Memorial Sloan Kettering Cancer Center, Stanford Medicine, the University of California, Los Angeles, the University of California, San Francisco, the University of Pennsylvania and The University of Texas MD Anderson Cancer Center), and will organize and support a portfolio of advanced, collaborative research efforts across this consortium.