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Lead Sr. Clinical Research Associate
Santa Ana, California
Clinical Research non-MD
Requisition ID: 8066171227
Johnson & Johnson Vision Surgical (JJVS), part of the Johnson & Johnson Family of Companies, is currently recruiting for a Sr. Lead Clinical Research Associate. JJVS manufactures products for the surgical ophthalmology business, and is headquartered in Santa Ana, California.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
The Johnson & Johnson Surgical Vision goal is improving sight throughout a patient’s lifetime. J&J Vision, Surgical is well positioned to address a full range of vision health needs for global markets: The No. 2 global provider of CATARACT products and a leader in presbyopia-correcting IOLs, the Global REFRACTIVE (LASIK) market leader, all supported with a CONSUMER EYE HEALTH diverse portfolio of solutions and drops. Johnson & Johnson Vision, Surgical has operations in the United States, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Our associates around the world are committed to expanding our brands and fortifying our position as the worldwide leader in the industry.
The Sr. Lead Clinical Research Associate will:
• Plan, guide, and report on the conduct of human clinical research studies required to enter new products into the marketplace or to expand product claims, in compliance with state and federal regulations, industry standards and corporate policies.
• Effectively manage multiple clinical studies/sites to assure accurate and timely initiation, enrollment, conduct and completion for assigned clinical trials while providing moderate level study management support.
• Apply applicable Corporate and Divisional policies and procedures, guidelines, standards and regulations.
• Under the support of a Study Manager, contribute to study design, development, conduct and closure.
• Lead project teams, providing input relative to study design, risk analysis and, appropriate clinical consultation relative to therapeutic area.
• Create, review and/or revise key study documents, including but not limited to protocol, investigator brochures, informed consent document templates, monitoring plans, and annotated monitoring visit report templates.
• Identify and evaluate investigators and investigative sites for assigned clinical trials.
• Assist in the development, testing and training for key clinical trial information systems (e.g., electronic data capture systems or electronic trial master file systems).
• Develop and implement a clinical trial training plan for internal and external personnel, including CRAs, CRA Assistants, and investigative site personnel.
• Provide leadership, protocol and monitoring support to CRAs allocated to assigned clinical trials, including resolution of team member conflict and communication issues, with support from Regional Managers and others, as needed.
• Responsible for study start-up activities including managing essential trial documents.
• Review and approve completed monitoring visit reports.
• Review study results, and contributing to final reports.
• Serve as primary contact for investigative site communication for each assigned site.
• Collaborate with investigative sites to ensure completion and appropriate submission of all required clinical trial documents prior to site initiation.
• Coordinate Institutional Review Board/ Ethics Committee (IRB/EC) approvals, as appropriate.
• Train investigative site personnel to ensure compliance with study requirements and GCP, including, but not limited to the protocol, IRB/EC instructions, industry guidelines, international standards and local and national regulations.
• Evaluate actual enrollment against assigned targets and working with assigned sites to meet, and whenever feasible, exceed enrollment targets.
• Assess eCRFs for trends in safety, effectiveness, and adherence to protocol.
• Manage study milestones and study metrics.
• Perform on-site monitoring activities for assigned investigative sites in compliance with the approved monitoring plan and SOPs, with specific tasks to include:
o Ensuring that all clinical trial documentation is properly reviewed, approved and filed within the Trial Master File, and is accessible to investigative site personnel.
o Ensuring investigational product and, as applicable clinical supplies accountability, handling and documentation are sufficient to continue, accurate, updated and appropriately delegated.
• Prepare, submit and file high quality monitoring visit reports and associated follow-up letters in a timely manner.
• Provide regular updates to the Investigator of assigned investigative sites, Study Manager and/or Lead CRA with respect to study conduct and compliance.
• Monitor overall progress of clinical trials by regularly attending project and/or clinical trial team meetings, reviewing team communications and sharing pertinent information with assigned investigative sites, Study Managers, Lead CRAs, CRAs and other clinical trial team members.
• Maintain audit/inspection readiness at assigned sites throughout the conduct and upon closure of clinical trials at assigned investigative sites.
• Ensure all equipment/supplies provided to investigative sites is appropriately reported to Study Manager.
• Identify training needs, developing materials and conducting training on clinical, therapeutic and/or compliance topics.
• Maintain effective working relationships with affiliate teams and external vendors.
• BS or equivalent years of experience required. Advanced degree preferred.
• 5+ years of clinical research experience with significant independent field monitoring experience is required.
• Medical Device industry experience is preferred.
• Knowledge of ophthalmology 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 is preferred.
• Ability to problem-solve is required.
• Effective communication via written, verbal and listening skills, with ability to effectively deliver training or informational presentations at internal or external meetings is preferred.
• Proficiency with MS Word, Excel and PowerPoint is required.
• Proven ability to operate in a home office environment with flexibility to travel and report to corporate offices, as appropriate is required.
• Ability to travel up to approximately 70% is required.
United States-California-Santa Ana
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