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Senior Clinical Research Associate
2 months ago
We are seeking a highly experienced and dedicated Senior Clinical Research Associate to join our team at Kumquat Biosciences Inc. As a Senior CRA, you will play a key leadership role in the planning, monitoring, and execution of oncology clinical trials.
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.
- Bachelor's degree in a related field (Life Sciences, Nursing, etc.), or equivalent experience.
- 4+ 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.
