{"id":3545280,"url":"https://alion.io/job/karius-sr-clinical-research-associate-2","title":"Sr. Clinical Research Associate","company":{"id":678685,"name":"Karius","domain":"kariusdx.com","url":"https://alion.io/company/kariusdx","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"posting_text","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Redwood City, United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":91790,"max":137684,"currency":"USD","period":"year","gross":null,"usd_annual":137684},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Gmail","optional":false},{"name":"Good Clinical Practice","optional":false},{"name":"Google Workspace","optional":false},{"name":"Machine Learning","optional":false},{"name":"Medidata Rave","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Veeva","optional":false}],"status":"closed","first_seen_at":"2026-10-30T18:33:19Z","employer_posted_date":"2026-10-30","last_verified_at":"2026-11-05T20:39:01Z","board_verified":false,"closed_at":"2026-11-05T20:39:01Z","days_open":6,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":6},"description":"About Karius\nKarius 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.\nPosition Summary\nThe Sr. Clinical Research Associate is responsible for advanced clinical site management and monitoring across Karius clinical programs, ensuring adherence to study protocols, ICH-GCP guidelines, sponsor procedures, and applicable regulatory requirements. Building on the full independent site ownership expected of a CRA II, the Sr. CRA manages more complex or higher-risk sites, applies advanced judgment to monitoring findings and emerging risks, and recommends corrective actions to support effective study execution. The Sr. CRA partners closely with Clinical Trial Managers and cross-functional teams and serves as a resource and mentor to less experienced Clinical Operations team members.\nWhy Should You Join Us?\nKarius 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.\nReports to: Sr. Manager, Clinical Site Operations\nLocation: Remote\nPrimary Responsibilities\nIndependently plan, conduct, and document on-site and remote monitoring visits, 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.\n\nApply a risk-based monitoring approach to evaluate site performance, protocol compliance, data quality, subject safety, and documentation completeness, and determine appropriate follow-up actions.\n\nConduct comprehensive 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 the study protocol.\n\nIndependently manage day-to-day site relationships, driving enrollment momentum, query resolution, protocol compliance, timely completion of study activities, and overall site performance.\n\nProactively identify, assess, and document monitoring findings, site-level risks, protocol deviations, compliance concerns, and data trends, and escalate significant or recurring issues with recommended corrective actions.\n\nPrepare and submit timely, high-quality monitoring visit reports and follow-up correspondence that clearly document site health, compliance status, findings, risks, required actions, and follow-up expectations.\n\nTrack monitoring findings and action items through resolution and verify completion and effectiveness during subsequent monitoring contacts.\n\nOversee the collection, review, and maintenance of essential regulatory and study documents to support ongoing inspection readiness.\n\nSupport and lead site-level study start-up activities, including site qualification, readiness assessments, SIVs, regulatory document collection, and site activation requirements.\n\nSupport and lead site-level closeout activities, including COVs, resolution of outstanding queries and monitoring findings, reconciliation activities, and completion of required site documentation.\n\nCollaborate closely with Clinical Trial Managers and cross-functional partners to provide site-level monitoring insights, risk assessments, and recommendations that inform study planning and operational decision-making.\n\nMentor junior CRAs and CTAs on monitoring standards, visit preparation and execution, documentation practices, site management, and issue resolution.\n\nMonitor subject safety throughout the study, including timely review and assessment of adverse events (AEs) and serious adverse events (SAEs), and promptly escalate safety signals or reporting concerns in accordance with sponsor and regulatory requirements.\n\nDevelop, track, and confirm implementation of corrective and preventive action plans (CAPAs) with investigative sites following protocol deviations, compliance concerns, or recurring performance issues, and verify effectiveness during subsequent monitoring visits.\n\nEvaluate and maintain Investigator Site Files (ISFs) and Trial Master File (TMF) documentation in accordance with sponsor SOPs, the TMF Reference Model, and study requirements, proactively identifying and resolving documentation gaps.\n\nFacilitate and support site staff training and retraining on protocol requirements, eClinical systems, specimen collection and handling, and study-specific procedures throughout study conduct.\n\nWhat’s Fun About the Job?\n 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.\nTravel: Travel required up to 80%.\nPhysical Requirements\nSubject 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.\nPosition Requirements\nBachelor's degree in a life sciences or health-related field, or equivalent combination of education and experience.\n\n5-8 years of clinical monitoring experience, including independent on-site and remote monitoring across multi-site studies.\n\nExperience monitoring studies for diagnostics, in vitro diagnostics (IVD), or regulated medical device products; familiarity with FDA device regulatory pathways strongly preferred.\n\nStrong working knowledge of ICH-GCP E6(R2) guidelines, FDA regulations, including 21 CFR Parts 11, 50, 54, 56, 312, and 812, and applicable local requirements governing clinical research.\n\nFamiliarity with risk-based monitoring (RBM) frameworks and central monitoring methodologies.\n\nDemonstrated ability to independently manage a portfolio of investigative sites, including enrollment tracking, query management, protocol deviation documentation, monitoring follow-up, and appropriate escalation of site-level risks.\n\nProficiency with electronic data capture (EDC) systems, such as iMediNet, Medidata Rave, Oracle InForm, or Veeva Vault EDC; clinical trial management systems (CTMS); and eTMF platforms, such as Veeva Vault TMF or Complion.\n\nProficiency with Microsoft Office Suite and Google Workspace, including Docs, Sheets, Slides, Gmail, and Drive.\n\nDemonstrated experience preparing clear, accurate, and high-quality monitoring visit reports with actionable findings and follow-up requirements.\n\nStrong written and verbal communication skills, including the ability to prepare concise monitoring reports, professional site correspondence, and clear study updates.\n\nDemonstrated ability to build and sustain effective working relationships with investigative sites, Clinical Trial Managers, and cross-functional stakeholders.\n\nExcellent organizational and time management skills, with the ability to manage a high-volume site portfolio, prioritize competing demands, and meet study timelines.\n\nAbility to exercise sound judgment, independently resolve complex site-level issues, and escalate significant concerns with recommended corrective actions.\n\nAbility to travel up to 80% of the time, including travel on short notice, and independently manage travel logistics.\n\nACRP Certified Clinical Research Associate (CCRA) or SoCRA Certified Clinical Research Professional (CCRP) certification preferred.\n\nExperience monitoring infectious disease, microbiology, molecular diagnostics, or related clinical studies preferred.\n\nExperience mentoring or training junior CRAs on monitoring practices, documentation standards, and site management techniques preferred.\n\nFamiliarity with laboratory-developed test (LDT) and CLIA regulatory frameworks preferred.\n\nPersonal Qualifications\nExcellent communication and interpersonal skills with the ability to build trusted relationships with investigative sites and internal stakeholders.\n\nStrong attention to detail, organization, and accountability.\n\nAdvanced problem-solving skills with the ability to assess issues and recommend practical solutions.\n\nAbility to exercise sound judgment and work independently in complex or ambiguous situations.\n\nProactive approach to identifying risks, resolving issues, and escalating with recommendations.\n\nCollaborative team player who mentors others and contributes to consistent, high-quality study execution.\n\nDisclaimer\nThe 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.\nAt 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  and we will accommodate qualified individuals with disabilities.","description_format":"text","description_chars":11158,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Molecular Diagnostics","Medical Laboratories"],"lifecycle":[{"event":"open","at":"2026-10-30T20:34:20Z"},{"event":"close","at":"2026-11-05T20:39:01Z"}],"visa":[],"liveness":null,"pay":{"stated_usd_annual":137684,"is_top_pay":false},"html_url":"https://alion.io/job/karius-sr-clinical-research-associate-2","json_url":"https://alion.io/job/karius-sr-clinical-research-associate-2.json","meta":{"generated_at":"2026-11-09T18:38:40Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":3551,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-10T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":678685},"rest":"https://alion.io/mcp/rest/get_company?id=678685"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fkarius-sr-clinical-research-associate-2"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fkarius-sr-clinical-research-associate-2"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fkarius-sr-clinical-research-associate-2"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/karius-sr-clinical-research-associate-2\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fkarius-sr-clinical-research-associate-2"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3545280}},{"tool":"search_jobs","arguments":{"company":"kariusdx.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3545280},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. Docs: https://alion.io/developers"}}