Clinical Research Associate jobs in United States
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Kumquat Biosciences Inc. · 1 month ago

Clinical Research Associate

Kumquat Biosciences Inc. is seeking a highly motivated and detail-oriented Clinical Research Associate (CRA) to join their team. The CRA will play a key role in the coordination and execution of global oncology clinical trials, ensuring compliance with regulatory guidelines and company protocols.

Alternative MedicineBiotechnologyOncologyTherapeutics
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H1B Sponsor Likelynote

Responsibilities

Support the study lead(s) in day-to-day operational management of one or more clinical trials
Ensure that investigative sites follow the study protocols, Standard Operating Procedures (SOPs), and regulatory requirements
May manage one or more key study vendors including central lab, IRT/RTSM, or CRO
Monitor and track study progress, patient recruitment, and data collection at investigational sites
Review and verify the accuracy, completeness, and quality of clinical trial data
Maintain and update essential trial documentation, including case report forms, regulatory documents, and investigator files
Collaborate with investigators, study coordinators, and other site staff to provide guidance and support
Identify and escalate any issues or deviations from the study plan to the appropriate parties
Assist in the preparation and submission of regulatory documents, such as Institutional Review Board (IRB) submissions
Ensure that the trial is conducted in compliance with Good Clinical Practice (GCP) guidelines and relevant regulations

Qualification

GCP knowledgeICH guidelinesClinical operations experienceMicrosoft Office proficiencyClinical trial management systemsElectronic data capture systemsVendor management experienceProtocolsOrganizational skillsCommunication skillsInterpersonal skillsTeamwork

Required

Bachelor's degree in a related field (Life Sciences, Nursing, etc.), or equivalent experience
2+ years of clinical operations experience or related drug development
Strong knowledge of GCP, ICH guidelines, and regulatory requirements for clinical research
Excellent organizational and time-management skills
Strong communication and interpersonal skills
Ability to work independently and as part of a cross-functional team
Proficiency in using Microsoft Office applications, clinical trial management systems, and electronic data capture systems
Willingness to travel to investigational sites as required

Preferred

Familiarity with early phase clinical trial protocols and procedures a plus
Prior vendor management experience a plus

Company

Kumquat Biosciences Inc.

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Kumquat Biosciences’ vision is to develop innovative therapies to bring about sustainable and life-changing benefits to cancer patients.

H1B Sponsorship

Kumquat Biosciences Inc. 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
2025 (2)
2024 (2)
2023 (1)
2022 (2)
2021 (2)

Funding

Current Stage
Early Stage
Total Funding
$175.92M
Key Investors
Loxo Oncology
2021-07-29Corporate Round· $70M
2021-02-16Undisclosed· $50M
2019-07-02Private Equity· $55.92M

Leadership Team

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Pingda Ren
Co-Founder, President & COO
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Carin Sandvik
VP of Finance
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Company data provided by crunchbase