Clinical Research Associate; Oncology Monitoring Experience Required
Abarca HealthSalary not specified
Full Time
Mid-level (3 to 4 years)
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, Healthcare, Life SciencesIndustries
Requirements
- Bachelor's degree in a life sciences or health-related field
Responsibilities
- 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
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the work location or remote policy for this position?
The position is located in Redwood City, CA (Hybrid) or Remote (USA).
What are the primary responsibilities of the Senior Clinical Research Associate?
The role involves performing on-site and remote monitoring visits, conducting source data verification, managing site communications, identifying and resolving risks, overseeing regulatory documents, and collaborating with the clinical study team.
What is the salary or compensation for this role?
This information is not specified in the job description.
What is the company culture like at Karius?
Karius is driven by a mission to conquer infectious diseases through genomic sequencing and machine learning, with a collaborative team of scientists, statisticians, engineers, and physicians focused on delivering life-changing impact on patient care at scale.
What makes a strong candidate for this Senior CRA position?
Strong candidates will have experience in clinical site management, monitoring, adherence to ICH GCP guidelines, source data verification, risk identification, and collaboration with clinical teams, with the ability to mentor junior CRAs.
Karius
Non-invasive diagnostic tests for infections
About Karius
Karius focuses on medical diagnostics for infectious diseases, offering the Karius Test, which detects over 1,000 pathogens from a single blood sample. This non-invasive test is quick and helps clinicians treat hospitalized patients by reducing the need for multiple invasive tests that can delay treatment. The Karius Test utilizes advanced genomics and artificial intelligence to identify microbial cell-free DNA (mcfDNA) in the bloodstream, providing insights into the pathogens responsible for infections. Karius sells these diagnostic tests to healthcare providers, aiming to offer a faster and less invasive alternative to traditional methods, ultimately saving lives and reducing healthcare costs. The company employs proprietary machine learning algorithms to analyze genomic data in real time, continuously updating its reference genome databases to enhance its diagnostic capabilities.
Redwood City, CaliforniaHeadquarters
2014Year Founded
$311.3MTotal Funding
SERIES_CCompany Stage
Biotechnology, HealthcareIndustries
51-200Employees
Benefits
Remote Work Options
Hybrid Work Options
Risks
Competition from AlphaFold 3 could overlap with Karius's genomic insights.
Rapid AI advancements by competitors may outpace Karius's technology.
Reliance on continuous funding rounds indicates potential financial instability.
Differentiation
Karius Test detects over 1,000 pathogens from a single blood sample.
The test uses advanced genomics and AI for rapid, non-invasive diagnostics.
Karius's proprietary algorithms analyze genomic data in real time.
Upsides
Karius secured $100M to expand its test beyond 400 U.S. hospitals.
FDA Breakthrough Device Designation boosts credibility and market potential.
Growing demand for non-invasive diagnostics aligns with Karius's offerings.
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