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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.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro | White Plains |Texas :
Abilene | Arlington | Austin | Boerne | Brenham | Bulverde | Carrollton | Cedar Hill | Corpus Christi | Corsicana | Dallas | Denton | El Paso | Fort Worth | Garland | Houston | Lakeway | Longview | Mcallen | North Richland Hills | Plano | Richardson | San Antonio | Seguin | Tyler | Waco |California :
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Albuquerque | Farmington | Santa Fe | Tucumcari |Pennsylvania :
Ambler | Bethlehem | Collegeville | Harrisburg | Lancaster | Marietta | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Pottstown | Radnor | Sellersville | Southampton | Spring House | West Chester | Wyomissing |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |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 | Newark | New Brunswick | 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 | Westfield | West Orange | Wharton | Whippany |Ohio :
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Baton Rouge | Monroe | New Orleans |Washington :
Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Wyoming :
Big Piney | Cokeville |Alabama :
Birmingham |Virginia :
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Bloomington | West Lafayette |Florida :
Boca Raton | Brooksville | Clearwater | Cooper City | Coral Gables | Coral Springs | Daytona Beach | Florida | Gainesville | Hollywood | Jacksonville | Maitland | Marsa | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Sarasota | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Idaho :
Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |North Caroline :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
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Concord | Lumberton | North Carolina |Michigan :
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Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
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Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
Breda |Noord Holland :
Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Uxbridge | North York | Richmond Hill | Renfrew | Mississauga | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Tel Aviv | Yavne | Netanya | Kfar Saba | Be'Er Sheva |Remote :
Springville | Belgium | Xzagreb | Slovakia | Bountiful | Regulatory Labeling Manager (NA and LATAM Only) | Bishop | Castlebar | Lenexa | Leinster | Nairobi | Riga | McFarland | Remote - Europe | Lousiana | Ireland | Green Way | Texas | Faridabad | Blue Bell | Remote, USA | Switzerland | Manipal | Medan | Tulsa | French | Victoria | Zaragoza | Remote - South America (Latin Americal) | Minnesota | Hungary | Remote - Africa | Melbourne | Remote - Middle East | Thailand | Remote | Hammond |Republic of Colombia :
Bogota |Williamson :
Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
Rabigh | Jeddah | Najran | King Abdullah Economic City | Riyadh | Khulais |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
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