Senior Clinical Research Associate

Kumquat Biosciences Inc.

. Support study lead(s) in day-to-day operational management of one or more clinical trials, with functional responsibility for vendor and/or regional management .

Posted 11/3/2026full-timeRemote • California • United StatesSenior💰 $100,000 - $130,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in clinical operations, including vendor management, regulatory compliance, and data quality assurance. Proficient in mentoring junior staff and managing clinical trial documentation while ensuring adherence to Good Clinical Practice guidelines.

Highest-signal resume keywords

Clinical Operations ExperienceVendor ManagementGood Clinical Practice (GCP)Regulatory ComplianceClinical Trial Management Systems

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial Data VerificationRegulatory Document PreparationPatient Recruitment StrategiesInformed Consent ManagementClinical Trial Protocol Familiarity

Soft Skills

Organizational SkillsTime-Management SkillsCommunication SkillsInterpersonal SkillsTeam Collaboration

Tools & Technologies

Microsoft OfficeClinical Trial Management SystemsElectronic Data Capture Systems

Industry Keywords

Clinical TrialsLife SciencesDrug DevelopmentICH GuidelinesInvestigational Sites

About the role

Key responsibilities & impact

Support study lead(s) in day-to-day operational management of one or more clinical trials, with functional responsibility for vendor and/or regional management
Provide mentorship and training to junior CRAs and site personnel
Act as a key point of contact for investigative sites, addressing inquiries and challenges and ensuring adherence to study protocols and regulatory requirements
Take a proactive role in patient recruitment strategies and data quality improvement
Conduct in-depth review and verification of clinical trial data for accuracy, completeness, and quality
Manage and maintain essential trial documentation, including informed consent forms, regulatory documents, and investigator files
Assist in preparing and submitting regulatory documents, including Institutional Review Board submissions
Ensure trials are conducted in compliance with Good Clinical Practice guidelines and relevant regulations

Requirements

What you’ll need

Bachelor's degree in a related field (Life Sciences, Nursing, etc.), or equivalent experience
6+ years of clinical operations experience or related drug development
Vendor/clinical service provider or regional site management experience required
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
Familiarity with early phase clinical trial protocols and procedures a plus
Sponsor experience preferred