Senior Clinical Research Associate

🔥 9 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $100k - $130k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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Kumquat Biosciences Inc.

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

🧬 Biotechnology

⚕️ Healthcare Insurance

💰 $70M Corporate Round on 2021-07

Healthcare • Biotechnology • Healthcare Insurance

Kumquat Biosciences Inc. is a biotechnology company dedicated to innovating life-changing medicines for cancer patients. With a focus on the KRAS pathway, Kumquat develops both single and combination therapies that target previously undruggable cancer types and stimulate the immune system to enhance therapeutic outcomes. Through a culture of bold innovation and collaboration, they strive to set new standards in cancer treatment, bringing the latest advancements from research to patient care.

📋 Description

• Support 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 • Act as a key point of contact for investigative sites, addressing inquiries and challenges and ensuring adherence to 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 investigator files • Assist in preparing and submitting regulatory documents, including Institutional Review Board submissions • Ensure trials are conducted in compliance with Good Clinical Practice 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

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