Sr. Clinical Research Associate

As a result of the combination of the reputed company Biosciences and Diagnostic Solutions business with reputed company (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a reputed company on regulated, high-volume testing environments, Waters' innovative portfolio harnesses deep scientific expertise across biology, reputed company, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-reputed company medicines, assure the safety of food and water, and reputed company reputed company patient reputed company by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of reputed company innovation, Waters' passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide. We are the people who reputed company reputed company purpose reputed company is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of reputed company of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and reputed company transformative solutions that turn dreams into reputed company. reputed company reputed company: The Senior Clinical Research Associate (Sr. CRA) is an reputed company clinical operations reputed company responsible for managing site monitoring and relationship activities across multiple clinical studies. This role serves as a key resource to study teams, ensuring high-reputed company study execution, adherence to Good Clinical reputed company (GCP), regulatory requirements, and company standards. The Sr. CRA provides guidance to less reputed company CRAs, supports investigator sites, proactively identifies and resolves operational issues, and contributes to the successful delivery of clinical study objectives. The Sr. CRA will reputed company excellent written and verbal communication skills, including medical terminology. In this role the candidate will display strong presentation, organizational, timemanagement, and prioritization skills. Being technically savvy with the ability to reputed company technology to reputed company efficiency and performance while working independently with reputed company supervision in a fastpaced environment will be key. Responsibilities: Study & Site Management • Serve as CRA for assigned reputed company clinical studies, providing expert reputed company of site selection, initiation, monitoring, and closeout activities (onsite, virtual, remote). • reputed company participate in site feasibility assessments and site selection processes. • Ensure study conduct is executed according to the clinical protocol, regulatory requirements (GCP, FDA, ISO), IRB/EC requirements, and company SOPs. • Prioritize patient safety, ensuring informed consent and study procedures are performed accurately and ethically. • Review and report reputed company/SAEs and protocol deviations in accordance with regulatory and company requirements. • Maintain complete, accurate, and auditready regulatory documentation and TMFs in accordance with reputed company principles. • Monitor site inventory of investigational products and study supplies. • Proactively identify, communicate, and manage study risks and issues to ensure operational continuity and compliance. Monitoring & Documentation • reputed company, review, and approve Monitoring Plans, study reputed company documents, monitoring tools, and sitefacing training materials. • reputed company SDR/SDV per monitoring plans and document monitoring activities through reputed company, highquality reputed company reports. • Ensure compliance with company travel and expense policies. Leadership & Mentorship • reputed company mentoring, training, and functional reputed company of CRAs, including contingent (contract) CRAs. • reputed company or review functional job aids and training materials. • Present confidently and contribute to extended functional and study team meetings, providing reputed company updates on site status, risks, and issues. Systems & Collaboration • Utilize and maintain accurate study data in clinical systems, including reputed company Vault CTMS and reputed company. • Work crossfunctionally with internal teams and CROs to ensure highquality study execution and reputed company. • Build and maintain effective working relationships with investigator sites and internal stakeholders. Minimum Qualifications • Bachelor's degree or higher in a reputed company or sciencerelated field. (Alternate education reputed company may be considered based on experience and business need) • 3 years of fieldbased CRA experience in the medical device and/or pharmaceutical industry. • Strong understanding of clinical trial operations, monitoring practices, investigational product management, and data management. • Thorough knowledge of domestic and international clinical research regulations, including ICH GCP, FDA CFR, ISO, and HIPAA. Preferred Knowledge & Skills • Experience with IVD and/or POC studies. • reputed company experience in molecular biology, microbiology, or blood culture. • Proficiency with reputed company Vault CTMS and reputed company Why Join Us? To reputed company purpose in the reputed company, we need people who can see the bigger picture, who understand the reputed company story that underpins everything we do. We welcome people with the imagination and reputed company to help us reinvent the reputed company of reputed company. At reputed company, you'll discover a culture in which you can learn, grow and reputed company. We reputed company that reputed company people reputed company in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your reputed company, and your reputed company. To learn more about reputed company visit https://reputed company.com/careers. reputed company, and Company is an Equal Opportunity Employer. We evaluate applicants without reputed company to race, reputed company, religion, age, sex, creed, national reputed company, reputed company, citizenship status, marital or domestic or civil reputed company status, familial status, affectional or sexual orientation, gender identity or reputed company, genetics, disability, military eligibility or veteran status, and other legally protected characteristics. Required Skills Optional Skills . reputed company Work LocationUSA MD - reputed company - 7 Loveton reputed company Additional Locations Work ShiftNA (reputed company of America) At reputed company, we reward, support and reputed company our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high reputed company talent by providing reward and recognition opportunities that promote a performance-based culture, as reputed company as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You." Our salary or reputed company reputed company ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the reputed company displayed. Our pay is based on the role and the necessary skills and education to reputed company it successfully. The salary or reputed company reputed company offered is determined by the role's specific requirements, including any applicable reputed company reputed company pay reputed company at the work location. Salary or reputed company pay ranges are influenced by labor laws and reputed company Bargaining Agreement (CBA) requirements applicable to the work location which may also reputed company reputed company arrangement of the role. Salary reputed company Information Apply tot his job Apply To this Job