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Karius · 1 month ago

Senior Clinical Research Associate

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

Full-time

Hybrid

Senior Level

5+ years exp

Karius is a life science, venture-backed clinical metagenomics company focused on advancing diagnostic science and technology for infectious diseases. The Senior Clinical Research Associate will manage clinical site activities to ensure compliance with study protocols and regulations, and may mentor junior CRAs to support high-quality monitoring in clinical trials.

BiotechnologyGeneticsHealth CareInformation TechnologyLife SciencePrecision Medicine

H1B Sponsor Likely

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

Qualification

Clinical trial experienceFDA regulations knowledgeICH-GCP guidelines knowledgeCTMS proficiencyCCRA/CCRP certificationCommunication skillsInterpersonal skillsAttention to detailProblem solving

Required

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

5+ years of clinical trial experience to include study monitoring

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

Excellent communication and interpersonal skills

Attention to detail

Advanced problem solving

Preferred

Experience with LDTs or in vitro diagnostic devices strongly preferred

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

CCRA/CCRP certification is desired

Company

Karius

Karius delivers genomic insights into infectious diseases, helping clinicians make critical, life-saving treatment decisions.

Founded in 2014

Redwood City, California, USA

51-200 employees

https://kariusdx.com

H1B Sponsorship

Karius has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2024 (1)

2021 (4)

Funding

Current Stage

Growth Stage

Total Funding

$354M

Key Investors

SoftBank Vision FundOxford Finance LLCDCVC

2024-05-02Series C· $100M

2020-02-24Series B· $165M

2018-11-30Debt Financing· $25M

Leadership Team

Alexander Ford

Chief Executive Officer

Tim Blauwkamp

Chief Scientific Officer, Co-founder

Recent News

General Catalyst

General Catalyst Portfolio

2026-01-06

synbiobeta.com

eGenesis Secures IND Clearance for EGEN-2784 in Kidney Transplant and Reports Significant Patient Progress

2025-09-12

Google Patent

Rapid, non-invasive detection and serial monitoring of infections in subjects …

2025-05-04

Company data provided by crunchbase