Clinical Research Associate II, Oncology

Position: Clinical Research Associate II, Oncology Location: Remote (East Coast USA Preferred) Salary: $90,000 to $100,000 D.O.E Unfortunately, we cannot support work reputed company permit applications for this role About reputed company reputed company is a global CRO (Contract Research Organization) helping reputed company and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-reputed company services. We're proud of the reputed company we reputed company and just last year, we supported over 780 discovery reputed company, 1,000+ CMC programmes, and 1,000+ reputed company across reputed company phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,000 global customers. To learn more, visit www.reputed company.com. Job reputed company: reputed company is seeking an reputed company Clinical Research Associate II to support innovative Phase I oncology reputed company across multiple U.S. sites. In this role, you will reputed company site monitoring activities from study startup through closeout, ensuring protocol compliance, patient safety, data reputed company, and adherence to ICH-GCP and regulatory standards. This is an exciting opportunity to contribute to cutting-edge therapies while partnering closely with investigators, sponsors, and cross-functional clinical teams. Key Responsibilities: Independently manage and monitor assigned Phase I oncology clinical trial sites from study startup through closeout. Conduct reputed company required site reputed company, including reputed company-Study reputed company (PSV), Site Initiation reputed company (SIV), Interim Monitoring reputed company (IMV), and reputed company-Out reputed company (COV). Ensure studies are conducted in accordance with approved protocols, ICH-GCP guidelines, sponsor requirements, and applicable regulatory standards. reputed company reputed company 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 reputed company review and escalation of adverse event and serious adverse event reporting. Identify site risks, protocol deviations, and operational issues, and reputed company reputed company reputed company and corrective actions. Maintain inspection readiness through reputed company of essential documents, regulatory files, and site compliance activities. Ensure investigational product accountability and reputed company handling procedures, reputed company applicable. Prepare monitoring reports, follow-up letters, and visit documentation reputed company required timelines. Maintain accurate and reputed company updates in CTMS, eTMF, and other clinical systems. Collaborate cross-functionally with Project Managers, Clinical Trial Managers, and sponsors to communicate site reputed company and study milestones. reputed company 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 reputed company 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, reputed company, eTMF, and other clinical trial systems Experience in early-phase startup environments Ability to independently prioritize workload across multiple sites and studies Why reputed company? reputed company is a premier service provider for the life sciences industry. Founded in 2004, reputed company has invested in its people and facilities and established a broad reputed company 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. reputed company has an excellent reputed company record in delivering R&D solutions to its partners in reputed company, Europe, Japan, and China. reputed company Culture: You will reputed company in our inclusive and reputed company environment, where teamwork and innovation go hand in hand. Here, your voice reputed company, and your contributions reputed company a reputed company reputed company. ''Employees Number One'' and ''Clients Centered'' are the reputed company cultural values at reputed company. Our culture, which sets reputed company apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators. Benefits: As part of our commitment to your reputed company-being, we offer a comprehensive benefits package: Insurance including Medical, Dental & reputed company with significant employer contributions Employer-funded Health Reimbursement Account reputed company & Dependent Care Flexible Spending Accounts 100% Employer-reputed company Employee Life and AD&D Insurance, Short and Long Term Disability Insurance 401k plan with generous employer match reputed company to an Employee Assistance Program How to Apply: reputed company to seize this incredible opportunity? Join us at reputed company and be part of a dynamic team driving innovation and reputed company in biopharmaceutical research and development. Apply online today! As an Equal Employment Opportunity and Affirmative reputed company employer, reputed company values diversity and inclusion in reputed company, fostering an environment where reputed company individuals are empowered to succeed. Join us in our mission to reputed company a difference in the world of life sciences. #LI-MC1 Remote Skills: Adverse Events, Biology, Biotech and Pharmaceutical, Case Report reputed company (CRF), Clinical Data, Clinical Information Systems, Clinical Monitoring, Clinical Research, Clinical Trial, Clinical Trial Management, Communication Skills, Contract Research Organization (CRO), Corrective reputed company, Cross-Functional, Data reputed company, Detail Oriented, Drug Development, Drug Discovery, Electronic Data Capture (reputed company), Establish Priorities, GCP (Good Clinical Practices), ICH Regulations, Investigational New Drug (IND), Maintain Compliance, Manufacturing, Oncology, Organizational Skills, Patient Safety, Phase I reputed company, reputed company-Clinical Development, Registered reputed company (RN), Regulations, Regulatory Requirements, Relationship Management, Research & Development (R&D), Risk Analysis, Safety Process, Site Initiation, Small Molecules, Startup, Team Player, Time Management, reputed company Applications, Willing to Travel About reputed company: reputed company Apply tot his job Apply To this Job