J&J Family of Companies Lead Clinical Research Associate in Santa Ana, California
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
As a Lead Clinical Research Associate, you will:
• Plan, guide, and report on the conduct of clinical research studies within compliance of state and federal regulations, industry standards and corporate policies.
• Effectively manage multiple clinical studies/sites to assure accurate and timely initiation, enrollment and conduct while providing moderate level study management support.
• Under the support of a Study Manager, contribute to study development, conduct and closure.
• Lead project teams, providing input to study design, risk analysis and clinical consultation relative to therapeutic area.
• Create, review and/or revise study documents, including but not limited to site informed consent documents, monitoring plans, and annotated monitoring visit reports.
• Assist with identifying investigators/ sites.
• Assist in testing and training study team on clinical trial systems (e.g., electronic data capture systems or electronic trial master file systems).
• Develop and implement training plans for personnel, including CRAs, CRA Assistants, and site personnel.
• Provide leadership and monitoring support to
• Responsible for study start-up activities including managing trial documents.
• Review and approve completed monitoring visit reports.
• Review study results with the study team and contribute to final reports.
• Coordinate Institutional Review Board/ Ethics Committee (IRB/EC) approvals.
• Train site personnel to ensure compliance with study requirements.
• Evaluate study enrollment and work with assigned sites to meet enrollment targets.
• Assess eCRFs for trends in safety, efficiency, and adherence to protocol.
• Perform on-site monitoring activities when needed.
• Ensure all documentation is filed within the Trial Master File.
• accountability, handling and documentation are sufficient to continue, accurate, updated and appropriately delegated.
• Prepare, submit and file high quality monitoring visit reports and follow-up letters for assigned sites in a timely manner.
• Lead and attend study team meetings and share pertinent information with study team members.
• Maintain audit/inspection readiness at assigned sites throughout the conduct and upon closure of clinical trials at assigned investigative sites.
• Ensue all equipment/supplies provided to investigative sites is appropriately reported.
• Maintain effective working relationships with affiliate teams and external vendors.
• Minimum education requires BS/BA required. Advanced degree preferred
• 2+ years of clinical research experience with independent field monitoring experience is required.
• Report into work at the Santa Ana JNJ campus as needed.
• Knowledge of ophthalmology is preferred.
• Medical Device industry experience is preferred.
• Strong knowledge and understanding of application of GCP, specifically as it applies to investigative site conduct of clinical trials, is required.
• Ability to successfully manage multiple competing priorities and adapt quickly to changing priorities.
• Ability to problem-solve is required.
• Effective communication via written, verbal and listening skills, with ability to effectively deliver training and informative presentations.
• Proficiency using MS Word, Excel and PowerPoint is required.
• Ability to travel up to approximately 35%.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-California-Santa Ana-
Johnson & Johnson Surgical Vision, Inc (6234)
J&J Family of Companies
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