Senior Clinical Research Associate

Karius is a life science, venture-backed clinical metagenomics company, focused on elevating patient care through microbial insights. We are committed to advancing diagnostic science and technology to optimize the diagnosis and treatment of infectious diseases. Through the use of genomics and AI, we are driven to improve the diagnostic landscape for infectious diseases. Karius delivers unprecedented diagnostic insight detecting microbial cell-free DNA circulating in the body to assist physicians to make rapid treatment decisions.

The Senior Clinical Research Associate is responsible for clinical site management and monitoring activities to ensure adherence to study protocols, GCP guidelines, and applicable regulations. This role performs on site and remote monitoring, reviews monitoring reports and site data for quality and trends, supports issue identification and resolution at the site level, and collaborates closely with the clinical study team. The Senior CRA may mentor junior CRAs, sharing best practices to support high quality monitoring and successful execution of clinical trials.

Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The company’s platform is already delivering unprecedented insights into the microbial landscape, providing clinicians with a comprehensive test capable of identifying more than a thousand pathogens directly from blood, and helping industry accelerate the development of therapeutic solutions. The products Karius offers today are some of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our tests are the result of some incredible work done by our scientists, statisticians, engineers, and physicians, all driven by the same mission. You, as part of the Karius team, will be able to see how directly your work has a life-changing impact on people, and at scale.

Reports to:  Director, Clinical Operations

Location: Redwood City, CA (Hybrid) or Remote (USA)

•  Perform on-site and remote monitoring visits for assigned sites in accordance with the Clinical Monitoring Plan, ICH GCP guidelines, and applicable local regulations.

•  Conduct source data verification to ensure Case Report Form (CRF) data is accurate, complete, and consistent with source documents and the protocol.

•  Manage day-to-day communication with assigned sites, supporting enrollment, query resolution, and overall site performance.

•  Proactively identify and document site level risks and issues, respond to study specific questions, and manage escalations through to resolution.

•  Oversee the collection, review, and maintenance of essential regulatory and study documents to ensure inspection readiness.

•  Collaborate closely with investigators and internal clinical teams to support effective study start up, conduct, and close out and to ensure successful trial execution.

•  Oversee the execution of clinical trial activities in accordance with Good Clinical Practices.

Karius is operating at the edge of what is now known to be possible in diagnostics. With that, comes a wave of new and incredible challenges and opportunities. To deliver on that value, you will be tapping into some of the most advanced technologies, architecting and innovating where the current solutions simply don't suffice. You will get to see how much your work really matters.

Travel: Travel required (up to 80%).

Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office, lab or clinical environment.

•  Bachelor's degree in a life sciences or health-related field.

•  5+ years of clinical trial experience to include study monitoring; experience with LDTs or in vitro diagnostic devices strongly preferred. 3+ years experience with a master's degree. 

•  Strong knowledge of FDA regulations, ICH-GCP guidelines, and clinical trial operations.

•  Ability to travel frequently, sometimes on short notice, and manage travel logistics effectively.

•  Proficiency in Microsoft Office and clinical trial management systems (CTMS) preferred.

•  CCRA/CCRP certification is desired.

This position requires excellent communication and interpersonal skills, attention to detail, and advanced problem solving.

The above job description is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. Responsibilities and duties may change or be adjusted to meet the needs of the company, and additional duties may be assigned as necessary. The job description is subject to change at any time at the discretion of Karius.

At Karius, we value a diverse and inclusive workplace and provide equal employment opportunities 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.