Senior Clinical Research Associate

4 weeks ago


San Diego, California, United States Kumquat Biosciences Inc Full time
Job Overview

Kumquat Biosciences Inc is seeking a highly skilled Senior Clinical Research Associate to lead the planning, monitoring, and execution of oncology clinical trials. As a key member of our team, you will be responsible for ensuring compliance with regulatory guidelines and company protocols.

Key Responsibilities
  • Support the study lead 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, fostering a culture of excellence and compliance.
  • Act as a key point of contact for investigative sites, addressing their inquiries, challenges, and ensuring adherence to the 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 other key investigator files.
  • Assist in the preparation and submission of regulatory documents, including Institutional Review Board (IRB) submissions.
  • Ensure that the trial is conducted in strict compliance with Good Clinical Practice (GCP) guidelines and relevant regulations.
Requirements
  • 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.

Salary Range: $89k - $134k



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