Senior Lead Clinical Research Associate (Remote)

The Senior 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. • Ensue 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. Qualifications 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 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%. At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. 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. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.] Homepage Working with Johnson & Johnson can change everything–including you. Explore impactful jobs, inclusive employee benefits, and how you can join us. Primary Location United States-California-Milpitas-510 Cottonwood Dr. Other Locations United States-California-Irvine, North America-United States-Florida-Jacksonville Organization Johnson & Johnson Surgical Vision, Inc (6234) Job Function R&D Requisition ID 2206000233W