Chief Clinical Research Lead
Oracle - Trenton, NJ
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Exciting Opportunity in Clinical Research! Are you ready to make a significant impact in the field of Oncology and Rare Disease? Join us at Oracle as a Chief Clinical Research Lead, where you'll play a pivotal role in spearheading groundbreaking projects globally. Our commitment to scientific advancements and technology integration means this is a truly remarkable time to be part of our team! Your Role: Lead Study Initiation: Develop feasibility questionnaires, identify potential study sites, and ensure optimal site selection in collaboration with Project Managers and Sponsors. Oversee Contracts and Budgets: Review and manage site contracts and budgets, working closely with CRA and contracting teams while involving contract specialists for legal matters. Ensure Regulatory Compliance: Collaborate with regulatory teams to meet all ethical committee requirements and support the preparation of essential site documents. Manage Study Sites: Supervise site activation and ongoing management, monitoring activities from feasibility to close-out, ensuring adherence to GCP and SOPs. Train and Guide CRAs: Mentor a diverse team of Clinical Research Associates, develop training materials, and ensure exceptional site management quality. Monitor Progress and Quality: Maintain study trackers, oversee CRA activities, identify critical issues, and review monitoring reports. Encourage Team Collaboration: Serve as the primary point of contact for the study team, sponsors, and CRAs, fostering strong relationships and continuous improvement. Travel for Site Visits: Be prepared to travel to clinical sites for training and monitoring activities as needed; flexibility is key. What We Are Looking For: Education: Bachelor's degree in Life Sciences, Medical Science, Pharmacy, Public Health, or equivalent, with at least three years of hands-on clinical research experience. Clinical Research Expertise: Minimum of 3 years as a CRA, with experience in site initiation and monitoring for clinical and non-interventional studies. Communication Skills: Outstanding spoken and written English proficiency (C1 level minimum); additional languages are a plus. Technical Proficiency: Familiarity with MS Office, EDC, CTMS, and readiness to learn new technical systems. Personal Attributes: Exceptional organizational and problem-solving skills, strong teamwork, initiative in optimizing processes, and ability to manage competing priorities in a fast-paced environment. Financial Management: Experience in reviewing site contracts, budgets, and invoices. Attention to Detail: Capability to work independently with meticulous execution of complex tasks. Location: This position is based at Oracle's office. Please note certain roles may require compliance with health mandates. Join Us! This is your chance to be part of a global leader driving innovative solutions in healthcare!
Created: 2026-03-10