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Senior Clinical Research Associate Leader

Oracle - East Montpelier, VT

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Job Description

Job Description Join us at Oracle during an exciting phase of Oncology and Rare Disease development. By focusing on scientific, targeted medicine and incorporating cutting-edge technology into healthcare, we are shaping the future of medicine. We are looking for a passionate and experienced Senior Clinical Research Associate Leader to join our dynamic Non-interventional Study team. What You Will Do Drive Study Start-up: Take the lead in creating feasibility questionnaires, identify and assess potential study sites, and work closely with Project Managers and Sponsors to ensure optimal site selection. Oversee Contracts and Budgets: Review and manage site contracts and budgets as per study requirements, collaborating with CRAs and contracting teams to engage contract specialists when needed. Ensure Regulatory Compliance: Collaborate with regulatory teams and CRAs to confirm adherence to ethical committee (EC) requirements, while supporting the preparation and submission of necessary site documentation. Lead Study Site Management: Direct site activation and management throughout the study lifecycle, ensuring compliance with GCP, SOPs, study protocols, and plans. Train and Coordinate CRAs: Mentor and train a cross-country team of Clinical Research Associates, develop project-specific training materials, and maintain high standards in site management. Monitor Progress and Quality: Create and maintain study trackers, oversee CRA activities and deliverables, identify critical issues, and review and approve monitoring reports. Foster Team Collaboration: Serve as the key liaison among the study team, Sponsors, study sites, and CRAs to promote strong relationships and facilitate continuous process improvements. Travel for Site Visits: Be prepared to travel for site monitoring and training as necessary. Flexibility for travel is required. Required Experience Education: Bachelor’s degree in Life Sciences, Medical Science, Pharmacy, Public Health, or a related field, with at least three years of clinical research experience. Clinical Research Expertise: Minimum of three years as a CRA, with experience in site initiation, Trial Master File (TMF) management, and monitoring for clinical and non-interventional studies. Communication Skills: Proficient in both spoken and written English (C1 level minimum); knowledge of additional languages is a plus. Technical Proficiency: Familiarity with MS Office, EDC, and CTMS, along with a readiness to learn and adapt to new technology systems. Personal Qualities: Demonstrated organizational and problem-solving skills, the ability to work well in diverse teams, and the initiative to enhance processes while managing multiple priorities in a fast-paced environment. Financial Management: Experience in reviewing site contracts, budgets, and invoices. Attention to Detail: Ability to work independently with a focus on precision and thoroughness in handling complex tasks. Disclaimer: Applicants for certain client-facing roles in the U.S. may need to comply with health mandates. Salary and Benefits: The annual salary range for this position is between $70,600 and $141,200. Eligible employees may also receive bonuses and equity. Our benefits package includes medical, dental, and vision insurance, short- and long-term disability coverage, life insurance, flexible spending accounts, a 401(k) plan with company match, paid vacation and holidays, and various perks designed to enhance your work-life balance. If you are seeking a significant and rewarding career opportunity, we invite you to apply for the Senior Clinical Research Associate Leader position at Oracle.

Created: 2026-03-10

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