Kumquat Biosciences Inc.

Clinical Research

• 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

Explore Senior Clinical Research Associate at Kumquat Biosciences Inc.. Review requirements and application details.

Senior Clinical Research Associate

Medical Director

• Perform ongoing clinical data review and analysis to ensure data integrity, identify trends, and support safety and efficacy assessments
• Review and interpret clinical data to identify trends, investigate unexpected findings, and provide meaningful insights to study teams
• Support medical monitoring activities, including review of adverse events, protocol deviations, and long-term safety and efficacy outcomes
• Provide input and execution of the clinical development plan by helping to develop and execute protocols and protocol amendments
• Actively participate in study/site start-up activities, site engagement, including SIVs and committees, and provide general clinical support to study teams
• Contribute to clinical and regulatory documents including Clinical Study Reports, informed consent forms, Investigator’s Brochures, and DSURs
• Serve as a partner to external stakeholders in various countries and support local needs
• Maintain up-to-date knowledge of the emerging treatment landscape in study-specific areas
• Cultivate peer-to-peer collaborations and support patient-centric study operations
• Work with colleagues across Kumquat to promote communication, community, and growth opportunities
• Ensure GCP/GVP compliance, data integrity, and a balanced risk-based approach
• Provide subject matter expertise supporting the design and execution of clinical trials and enabling projects across geographies
• Contribute to the outcomes of clinical trials and enabling projects
• Apply ICH, GCP, and regulatory guidelines within clinical trials or enabling activities
• Participate in identifying vendors, building relationships with sites and investigators, and supporting trial execution
• Work closely with investigators and clinical site staff

Explore Director, Clinical Scientist at Kumquat Biosciences Inc.. Review requirements and application details.

Open roles

Senior Clinical Research Associate

Director, Clinical Scientist