Position Summary

The CRA II performs independent on site and remote monitoring across assigned sites and studies within Karius' diagnostic clinical programs. This role manages site relationships with a high degree of autonomy, conducts rigorous source data verification (SDV) and source data review (SDR), and drives timely resolution of findings, queries, and protocol deviations. The CRA II is a dependable operational contributor who proactively identifies risks and escalates issues with appropriate recommendations, while maintaining inspection ready documentation.

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 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:  Sr. Manager, Clinical Site Operations

Location:  Remote (East or Midwest Area)

Primary Responsibilities

• Independently perform on-site and remote monitoring visits for assigned sites, including site qualification visits (SQVs), site initiation visits (SIVs), interim monitoring visits (IMVs), and closeout visits (COVs), in accordance with the Clinical Monitoring Plan, study protocols, ICH-GCP guidelines, sponsor procedures, and applicable regulatory requirements.

• Conduct source data verification (SDV) and source data review (SDR) to ensure Case Report Form (CRF) data is accurate, complete, and consistent with source documentation and study requirements.

• Manage day-to-day relationships with assigned investigative sites, including enrollment progress, query resolution, protocol compliance, and completion of study activities.

• Identify and document site-level risks, protocol deviations, compliance concerns, and data discrepancies, and escalate issues appropriately.

• Prepare and submit accurate and timely monitoring visit reports and follow-up correspondence documenting site status, findings, and required actions.

• Track monitoring findings, site action items, and outstanding issues through resolution.

• Support the development and tracking of corrective and preventive action plans (CAPAs) following protocol deviations or compliance concerns.

• Review and maintain essential regulatory and study documents, including Investigator Site Files (ISFs), and support Trial Master File (TMF) completeness and inspection readiness.

• Conduct site readiness assessments and provide site staff training on study protocols, procedures, systems, and specimen collection and handling requirements.

• Support study start-up and closeout activities, including site activation, outstanding query resolution, reconciliation, and completion of required documentation.

• Review adverse event (AE) and serious adverse event (SAE) documentation and escalate discrepancies or potential safety concerns in accordance with study requirements.

• Track and reconcile specimen collection kit inventory, specimen handling documentation, and chain-of-custody records.

• Maintain accurate and timely information across EDC, CTMS, and eTMF systems.

• Collaborate with Clinical Trial Managers and cross-functional study team members to communicate site status, monitoring findings, operational issues, and protocol deviations.

• Serve as the primary day-to-day point of contact for assigned sites and may provide informal guidance to less experienced CRAs or CTAs.

• Serve as a day to day point of contact for assigned sites, responding promptly to site questions and escalating as needed.

What's Fun About the Job?

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 60-70%. 

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, with periodic travel to investigator sites.

Position Requirements

• Bachelor's degree in a life sciences or health-related field, or equivalent combination of education and experience.

• Three to five years of clinical research monitoring experience, including independent site management responsibilities.

• Working knowledge of ICH-GCP E6(R2) guidelines and applicable clinical research regulations.

• Demonstrated ability to independently plan, conduct, and report on on-site and remote monitoring visits.

• Proficiency with EDC, CTMS, and eTMF systems.

• Strong written and verbal communication skills, with the ability to build effective working relationships with site staff and cross-functional teams.

• Sound judgment in identifying, escalating, and helping resolve site-level risks and compliance issues.

• Strong organizational skills with the ability to manage multiple sites and competing priorities.

• Valid driver's license required.

• Preferred: Experience monitoring diagnostic, IVD, or molecular biology clinical studies.

• Preferred: ACRP (CCRA) or SoCRA (CCRP) certification, or active progress toward certification.

• Preferred: Experience mentoring or supporting the onboarding of junior CRAs.

Personal Qualifications

• Strong communication and interpersonal skills with the ability to build effective relationships with investigative sites and internal partners.

• Strong attention to detail, organization, and follow-through.

• Sound problem-solving skills and ability to escalate issues appropriately.

• Demonstrated accountability, integrity, and reliability.

• Ability to work independently, manage competing priorities, and meet study timelines.

• Collaborative team player who is adaptable and committed to high-quality clinical research execution. 

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.

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.