Description
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.
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.
Skills Required
- Bachelor's degree in a related field such as Life Sciences or Nursing, or equivalent experience
- 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 clinical research regulatory requirements
- 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
- Familiarity with early-phase clinical trial protocols and procedures
- Sponsor experience
What We Do
Kumquat Biosciences’ vision is to develop innovative therapies to bring about sustainable and life-changing benefits to cancer patients. We are committed to translate breakthrough science to innovative medicines by combining internal expertise in drug discovery and development, with external collaboration with academics. Kumquat brings together an accomplished management team with proven track record in discovering and developing innovative oncology medicines. The founding team has previously co-founded Intellikine, Araxes/Wellspring Biosciences and Kura Oncology. Kumquat Biosciences currently focuses on multiple first-in-class programs including targeted therapy as well as immunotherapy. Kumquat is funded by leading biotech venture investors as well as a pharmaceutical corporate venture.
