Senior Clinical Research Associate

Kumquat Biosciences Inc • San Diego, CA

2h

About The Position

Kumquat Biosciences is seeking an experienced Senior Clinical Research Associate (Senior CRA) to take a leadership role in planning, monitoring, and executing oncology clinical trials. The role is responsible for ensuring trials are conducted in compliance with regulatory guidelines and company protocols.

The Senior CRA supports day-to-day operational management of one or more clinical trials, including functional responsibility for vendors and/or regional management. The role provides mentorship and training to junior CRAs and site personnel, serves as a key contact for investigative sites, contributes to patient recruitment and data quality, reviews trial data, maintains essential documentation, and assists with regulatory submissions.

Requirements

• Bachelor's degree in a related field such as Life Sciences or Nursing, or equivalent experience.
• At least 6 years of clinical operations experience or related drug development experience.
• Vendor/clinical service provider or regional site management experience.
• 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 with Microsoft Office applications, clinical trial management systems, and electronic data capture systems.
• Willingness to travel to investigational sites as required.

Nice To Haves

• Familiarity with early-phase clinical trial protocols and procedures.
• Sponsor experience.

Responsibilities

• Support study leads in the 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.
• Serve as a key point of contact for investigative sites, addressing inquiries and challenges and ensuring adherence to study protocols and regulatory requirements.
• Contribute proactively to patient recruitment strategies and data quality improvement.
• Review and verify clinical trial data for accuracy, completeness, and quality.
• Manage and maintain essential trial documentation, including informed consent forms, regulatory documents, and investigator files.
• Assist with preparation and submission of regulatory documents, including Institutional Review Board (IRB) submissions.
• Ensure trials comply with Good Clinical Practice (GCP) guidelines and relevant regulations.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior