Sr.CRA/Clinical Trial Manager | Karius

Sr.CRA/Clinical Trial Manager

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

At Karius, we value a diverse and inclusive workplace and provide equal employment opportunity for all applicants and employees and are committed to honor and invest in the full diversity of people, in our hiring, recruiting and development of employees across the Company.  All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual’s race, color, sex, gender identity and gender expression (including transgender individuals who are transitioning, have transitioned, or are perceived to be transitioning to the gender with which they identify), religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application due to a disability, please contact us at recruiting@kariusdx.com and we will accommodate qualified individuals with disabilities.

 

Full-time
Redwood City, CA