Sr.CRA/Clinical Trial Manager at Karius
Redwood City, CA, US

Karius is a venture-backed life science startup focused on transforming the way infectious diseases are diagnosed.  Combining Next-Generation Sequencing and proprietary data analysis, we can identify over 1,000 pathogens from a single blood sample with typical turnaround time in one business day. By unlocking the information present in microbial cell-free DNA, we're helping doctors quickly solve their most challenging cases, with a future vision of accelerating clinical trials, discovering new microbes, and reducing patient suffering worldwide.
 
Position Summary

Karius is on a mission to help clinicians do more for their patients by bringing the genomic revolution to infectious disease diagnosis. The Sr.CRA/Clinical Trial Manager reports to the Director of Clinical Operations. We are looking for an experienced self-motivated, critical thinker that can work independently within a high performing clinical operations team. In this role, the Sr.CRA/Clinical Trial Manager
is responsible for the management of a portfolio of projects and studies across different clinical study programs that applies Karius’ novel diagnostic technology within specific clinical indication(s).
 
Reports to           Director, Clinical Operations
Location               Redwood City, CA

Responsibilities:

·       Drives all aspects of clinical trial management and process from site selection, qualification, initiation, planning, execution, and closure while maintaining compliance with ICH and GCP guidelines
·       Acts as the operational focal point and coordinates the clinical trial efforts for both Karius sponsored and/or collaborative studies
·       Responsible for the project scope, timeline, budget, contracts, communication, risk assessment for clinical studies, as assigned
·       Assists with protocol development and report writing, as requested
·       Responsible for Institutional Review Board (IRB) preparations and submissions
·       Assists with development of Standard Operating Procedures and best practices, as requested
·       Monitors and controls the execution of the clinical study and coordinates clinical team
·       Reviews and/or creates study documents and tools for the execution of the study and ensure compliance with protocol and overall clinical objectives
·       Ensures adequate clinical staff training and compliance, including providing Clinical Research Associates with project-specific training and regular meetings with them
·       Collaborates with other relevant groups to identify qualified clinical study sites, and vendors required in the execution of planned clinical studies
·       Oversees qualification, monitoring of data quality and management of clinical study sites including arranging, conducting and overseeing all site visits
·       Build strong relationships with sites and internal teams
·       Responsible for study forecasting, metrics and reporting tools
·       Mentor junior CRAs, as needed
 
Travel: Travel required 25-35%. International travel may be required in future

Physical Requirements:

Work is generally performed in an office. Subject to extended periods of sitting and/or standing, computer work and moderate noise levels.
 
Position Requirements:

·            Bachelor’s Degree in scientific or health related field or equivalent years of experience
·            5+ years Clinical Research and development experience required, including relevant Clinical Trial Management experience
·            Experience with project, vendor, contract, and clinical research staff management
·            Advanced knowledge of Good Clinical Practice (GCP) and current knowledge of FDA regulations of clinical trial regulation is expected
·            Experience with Institutional Review Board (IRB) preparations and submission is required
·            Experience writing, reviewing and editing clinical protocols and study reports
·            Must demonstrate ability to scale programs
·            Valid driver’s license
 
Personal Qualifications:

·       Must be an excellent communicator and able to summarize key findings, risks in a succinct manner
·       Ability to anticipate and identify potential roadblocks to meeting goals and identify corrective actions
·       Display a high level of commitment and professionalism and is truly passionate about being in the cutting edge of science and generating the appropriate clinical evidence
·       Excellent written and verbal communication skills, including ability to effectively present information and respond to questions from project teams, external vendors, KOLs, and customers
·       Ability to work independently, collaboratively and manage deadlines
·       Exemplary project management skills with the ability to build schedules and mitigate against timeline delays
 

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