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Job Title: Senior Clinical Research Associate
Location: Redwood City, CA (Hybrid) or Remote (USA)
Employment Type: Temporary Agency Worker / Remote
Company Overview:
Karius is a cutting-edge life science startup revolutionizing the understanding of microbial pathogens through genomic sequencing and machine learning. Their innovative platform provides unprecedented insights into microbial landscapes, enabling clinicians to identify over a thousand pathogens directly from blood and accelerating the development of therapeutic solutions. As part of the Karius team, your work will have a life-changing impact on patients worldwide.
Position Summary:
The Senior Clinical Research Associate (Sr. CRA) is responsible for supporting clinical studies by ensuring data accuracy, source documentation traceability, and assisting in site management and clinical study materials development. This contract position is pivotal to ensuring the successful execution of clinical trials.
Primary Responsibilities:
Site Monitoring: Support the Clinical Trial Manager (CTM) in site identification, qualification, initiation, monitoring, and close-out activities.
On-Site and Remote Monitoring: Conduct site visits to ensure adherence to study protocols, regulatory requirements, and ICH-GCP guidelines. Perform Source Data Verification (SDV) and case report form (CRF) completion in the EDC system.
Regulatory Documentation: Track and follow up on regulatory submissions, IRB approvals, recruitment progress, and data collection timelines. Maintain the Investigator Site File (ISF) and Trial Master File (TMF) to ensure audit-readiness.
Protocol-Specific Training: Provide training to investigators, study coordinators, and site staff on study procedures and compliance expectations.
Investigational Product Management: Oversee investigational product (IP) tracking, temperature-controlled storage, inventory management, and accountability at clinical sites.
Recruitment & Retention: Develop and implement patient recruitment and retention strategies. Monitor site enrollment performance and escalate concerns to the CTM.
Site Issue Resolution: Identify and resolve site-level issues and contribute to the development of corrective and preventive action (CAPA) plans.
Compliance & SOPs: Ensure site adherence to company SOPs, study protocols, FDA regulations, and international ICH-GCP standards.
Cross-Functional Collaboration: Collaborate with internal teams, site teleconferences, and investigator meetings to ensure trial objectives and timelines are met.
Inspection Readiness: Support inspection readiness and participate in audits and regulatory inspections as needed.
Vendor Management: Assist with the oversight of vendors such as central labs, imaging providers, and logistics services.
Study Documentation: Participate in the review and development of study documents such as protocols, informed consent forms, monitoring plans, and CRFs.
Additional Tasks: Perform additional tasks and special projects as required to support clinical trial operations.
Position Requirements:
Education: Bachelor’s degree in Life Sciences, Nursing, or a related field.
Experience: Minimum of 4-6 years of experience in clinical research, with IVD experience preferred. Prior site monitoring experience is essential.
Skills & Knowledge:
Solid understanding of clinical trial processes and regulatory requirements (FDA, EMA).
Proficiency with EDC systems, CTMS, and eTMF.
Strong communication, problem-solving, and organizational skills.
Ability to work independently and collaboratively in a fast-paced environment.
Strong attention to detail and a commitment to high-quality work.
Compensation & Benefits:
Salary: Competitive and dependent on experience.
Work Environment: Hybrid or remote, depending on location and company policies.
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B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Kurkumbh | Kurla | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane | Vikhroli |Odisha :
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Rangpo |Tamil Nadu :
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Digha | Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |Arkansas :
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Adelanto | Alameda | Albion | Arcata | Atherton | Berkeley | Brisbane | Burlingame | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hayward | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Millbrae | Milpitas | Morgan Hill | Mountain View | Nevada | Novato | Oakland | Orange | Pacheco | Palo Alto | Pasadena | Pleasanton | Pomona | Redding | Redwood City | Riverside | Roseville | Sacramento | San Bernardino | San Carlos | San Diego | San Francisco | San Gabriel | San Jose | San Mateo | San Rafael | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | St. Helena | Stanford | Stanton | Stockton | Sunnyvale | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |Colorado :
Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |D.C :
Washington |Delaware :
Wilmington |Florida :
Boca Raton | Brooksville | Clearwater | Coral Gables | Coral Springs | Daytona Beach | Gainesville | Hollywood | Jacksonville | Maitland | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Georgia :
Atlanta | Augusta | Rome |Hawaii :
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Bangor | Brewer |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
Hebron | Nebraska City |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |New Mexico :
Albuquerque | Farmington | Santa Fe | Tucumcari |New York :
Albany | Biddle | Brooklyn | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |North Carolina :
Concord | Lumberton | North Carolina |North Caroline :
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Dickinson |northeastern :
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Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Montgomery | Norwood | Oregoina | oxford | Waynesville |Oklahoma :
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Budapest |Istanbul :
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Dún Laoghaire |Meath :
Dunboyne |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Tipperary :
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Donegal |China :
China | Quarry Bay |Hubei :
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Dalian |Republic of China :
Beijing |Shanghai Sai :
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Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
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Ballina | Sydney |Queensland :
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Haarlem |North Brabant :
Breda |South Holland :
Leiden |North Yorkshire :
Harrogate |Oxfordshire :
Witney |South Yorkshire :
Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Mississauga | Uxbridge | North York | Richmond Hill | Renfrew |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
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Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Paris | Lyon |Attica :
Koropi | Athens |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Yavne | Tel Aviv | Be'Er Sheva | Kfar Saba | Netanya |Italy :
Italy |Lombardy :
Rho |Japan :
Saitama | Japan |Tokyo :
Otemachi |Kazakhstan :
Almaty |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kuala Lumpur :
Kuala Lumpur |Mexico :
Ciudad de México |North Island :
Auckland |Lima Region :
Lima |Cebu Province :
Cebu City |Philippines :
Manila |Mazovia :
Warsaw |Remote :
Lenexa | McFarland | Melbourne | Remote | Victoria | Switzerland | Remote - Europe | Remote - South America (Latin Americal) | Remote - Africa | Remote, USA | Remote - Middle East |Bucharest :
Bucharest |Makkah :
Jeddah | Rabigh | King Abdullah Economic City | Riyadh | Khulais | Najran |Nišava District :
Niš |Singapore :
Singapore |South Africa :
South Africa | Midrand |Brazil :
Brazil | Sao paulo |South America :
Argentina | Peru |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
Bangkok |Kyiv Oblast :
Kyiv |Dubai :
Dubai |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |