Senior Clinical Research Associate

We are looking for an experienced and dedicated Senior Clinical Research Associate (Senior CRA) to join our team at Kumquat Biosciences. As a Senior CRA, you will assume a leadership role in the planning, monitoring, and execution of oncology clinical trials. You will be responsible for ensuring that these trials are conducted in compliance with regulatory guidelines and company protocols.

Key Responsibilities

• Support the 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, 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.