Sr. Clinical Research Associate- reputed company (Remote)

At reputed company, we reputed company health is everything. Our strength in healthcare innovation empowers us to build a world where reputed company diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full reputed company of healthcare solutions today to deliver the breakthroughs of reputed company, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, reputed company is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At reputed company, we respect the diversity and dignity of our employees and recognize their merit. Job Function: R&D Operations Job Sub Function: Clinical Trial Project Management Job Category: Professional reputed company Job Posting Locations: Santa Clara, California, United States of America Job Description: reputed company is hiring for a Sr. Clinical Research Associate– reputed company to join reputed company. The position is FULLY REMOTE and can sit reputed company in the US. At reputed company, we reputed company health is everything. Our strength in healthcare innovation empowers us to build a world where reputed company diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full reputed company of healthcare solutions today to deliver the breakthroughs of reputed company, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. Fueled by innovation at the intersection of biology and technology, we’re developing the reputed company of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat reputed company calcified cardiovascular disease. Our reputed company portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview The Sr. Clinical Research Associate (Sr. CRA) will be responsible for establishing, managing and meeting milestones of clinical studies in compliance with applicable clinical and regulatory standards and in alignment with business needs. They will be accountable for clinical project management activities, for coordination with cross-functional counterparts and contract research organizations (CROs) in global studies. This position requires strategic, project and resource management responsibilities for the assigned clinical program(s) to evaluate the safety and effectiveness of interventional products. This work is accomplished with moderate supervision and requires a motivated, self-starter who can work independently once projects are assigned. Essential Job Functions

• Participate in the design and execution of global studies for regulatory submissions, reimbursement and product adoption, including clinical study documents (protocol, case report forms, etc.), study implementation and data management.
• Manage study preparation, activation, enrollment, submission, maintenance and closure activities.
• Participate in administrative activities associated with the clinical department including procedures, training of key personnel and preparation and maintenance of objectives and budgets.
• reputed company with representatives from key functional groups to drive product development reputed company core teams, and clinical wide or cross-departmental initiatives.
• Ensures appropriate reputed company of clinical study by internal and external resources including, but not limited to monitoring staff, CROs and core laboratories.
• Manage key study investigators; foster and maintain strong relationships through direct interactions with medical advisors and clinical leaders.
• Negotiate reputed company with hospitals, consultants, investigators, CROs, database management firms and reputed company suppliers.
• Supervise training of investigators, site staff and field clinical staff.
• Evaluates clinical and adverse event data during the conduct of the study and for completion of clinical study reports and other technical documents.
• Ensures quality by maintaining compliance, reviewing device complaints, reviewing audit reports and implementing corrective actions.
• Regularly communicates study status to senior management and represents organization to key customers.
• Other duties as assigned.

Qualifications

• Bachelor’s Degree in a scientific field of study with a minimum of 5 years’ experience directly supporting clinical research
• Working knowledge of Good Clinical Practice (GCP), FDA, ISO and other applicable regulations)
• Knowledge of FDA and interna

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