Job description
About Karius
Karius is a venture-backed life science startup that is transforming the way pathogens and other microbes are observed throughout the body. By unlocking the information present in microbial cell-free DNA, we’re helping doctors quickly solve their most challenging cases, providing industry partners with access to the microbial landscape to accelerate biomarker discovery and clinical trials, discover novel microbes, to ultimately reduce patient suffering worldwide.
Position Summary
This contract position is responsible for ensuring that data collected for clinical studies is accurate, plausible, and traceable to source documentation, assisting in site management ,and clinical study materials development.
Why Should You Join Us?
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 Karius test we provide today is one of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our test is 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: Close to a major airport
Primary Responsibilities:
• Support the Clinical Trial Manager in site identification, qualification, initiation, routine monitoring, and close-out activities.
• Conduct site monitoring visits (remote and onsite) to ensure adherence to study protocols, regulatory requirements, and ICH-GCP guidelines.
• Perform Source Data Verification (SDV) and ensure timely and accurate completion of case report forms (CRFs) in the electronic data capture (EDC) system.
• Track and follow up on regulatory document submissions, Institutional Review Board (IRB) approvals, recruitment progress, and data collection timelines.
• Ensure timely collection, maintenance, and filing of essential regulatory documents in the Investigator Site File (ISF) and Trial Master File (TMF), ensuring audit-readiness at all times.
• Provide protocol-specific and GCP training to investigators, study coordinators, and site staff, ensuring a thorough understanding of study procedures and compliance expectations.
• Oversee investigational product (IP) tracking, temperature-controlled storage, inventory management, and accountability at each clinical site.
• Develop, support, and implement site-specific patient recruitment and retention strategies; monitor site enrollment performance and escalate concerns to the CTM.
• Document all monitoring activities, observations, protocol deviations, and site correspondence through detailed visit reports, follow-up letters, and issue escalation when necessary.
• Assist in the identification and resolution of site-level issues; contribute to the development and execution of corrective and preventive action (CAPA) plans.
• Ensure site adherence to company Standard Operating Procedures (SOPs), study protocols, FDA regulations, and international ICH-GCP standards.
• Participate in internal team meetings, site teleconferences, and investigator meetings as needed to support trial execution.
• Collaborate with cross-functional teams to ensure trial objectives and timelines are met.
• Support inspection readiness and participate in audits and regulatory inspections as needed.
• Assist with vendor management and oversight (e.g., central labs, imaging providers, logistics services).
• Participate in the review and development of study documents, including protocols, informed consent forms, monitoring plans, and case report forms.
• Perform additional tasks and special projects as required to support clinical trial operations and continuous process improvement initiatives.
Physical Requirements
• 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.
Position Requirements
• Bachelor’s degree in Life Sciences, Nursing, or a related field is required.
• Minimum of 4-6 years of experience in clinical research, including IVD experience.
• On-site or remote site monitoring experience and ability to monitor multiple sites and complex studies.
• Solid understanding of clinical trial processes, ICH-GCP, and regulatory requirements (FDA, EMA).
• Proficiency with EDC systems, CTMS, eTMF.
• Excellent communication, problem-solving, and organizational skills.
• Ability to work independently and collaboratively in a fast-paced, dynamic environment.
• Strong attention to detail and commitment to delivering high-quality work.
Disclaimer
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.
Equal Opportunity Employer
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 [email protected] and we will accommodate qualified individuals with disabilities.
