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Clinical Research Associate II, Oncology
- New York, New York, United States
- New York, New York, United States
À propos
Independently manage and monitor assigned Phase I oncology clinical trial sites from study startup through closeout. Conduct all required site visits, including Pre-Study Visits (PSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV). Ensure studies are conducted in accordance with approved protocols, ICH-GCP guidelines, sponsor requirements, and applicable regulatory standards. Perform source data verification (SDV), review eCRFs/CRFs, and ensure accuracy, completeness, and timeliness of clinical trial data. Build and maintain effective working relationships with investigators, coordinators, and site personnel. Monitor patient safety processes, including timely review and escalation of adverse event and serious adverse event reporting. Identify site risks, protocol deviations, and operational issues, and drive timely resolution and corrective actions. Maintain inspection readiness through oversight of essential documents, regulatory files, and site compliance activities. Ensure investigational product accountability and proper handling procedures, when applicable. Prepare monitoring reports, follow-up letters, and visit documentation within required timelines. Maintain accurate and current updates in CTMS, eTMF, and other clinical systems. Collaborate cross-functionally with Project Managers, Clinical Trial Managers, and sponsors to communicate site progress and study milestones.
What We Are Looking For:
Bachelor's degree, RN, or equivalent combination of education and relevant experience; life sciences background preferred 3+ years of clinical monitoring experience within sponsor, CRO, or investigative site environments Hands-on oncology monitoring experience required, including Phase I studies Strong knowledge of ICH-GCP guidelines and applicable regulatory requirements Ability and willingness to travel up to 30% based on study needs Excellent organizational skills with strong attention to detail Strong communication skills and ability to manage site relationships effectively Experience using CTMS, EDC, eTMF, and other clinical trial systems Experience in early-phase startup environments Ability to independently prioritize workload across multiple sites and studies
Why Pharmaron? Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China. Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators. Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package:
Insurance including Medical, Dental & Vision with significant employer contributions Employer-funded Health Reimbursement Account Healthcare & Dependent Care Flexible Spending Accounts 100% Employer-paid Employee Life and AD&D Insurance, Short and Long Term Disability Insurance 401k plan with generous employer match Access to an Employee Assistance Program
How to Apply: Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today! As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.
Compétences linguistiques
- English
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