At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex 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 spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research – Non-MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Irvine, California, United States of America, Jacksonville, Florida, United States of America

Job Description:

We are searching for the best talent to join our Vision team as a Staff Clinical Trial Specialist located in Jacksonville, FL or Irvine, CA.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Purpose: The Staff Clinical Trials Specialist manages study conduct under the guidance of a senior level manager ensuring that operating procedures and company policies are followed. The Staff Clinical Trial Specialist develops and manages timelines, resourcing, and budget for assigned clinical trials. They build cross-functional support for innovative solutions and facilitate successful study team behavior. They partner with Research & Development and Research Scientists/Clinicians to ensure study results and timelines are met. They maintain relationships externally with strategic partners, monitors, Clinical Research Organizations, and study site investigators/personnel. They adhere to environmental policy, procedures, and support department environmental objectives. They engage in Credo-based decision-making where our responsibility is to our patients and doctors.

You will:

• Own processes and information required to complete and support the clinical trial including clinical trial project plan, project timelines, resourcing, budget plans, and statements of work
• Accountable for the preparation and finalization of key clinical documents which include the informed consent, case report forms, and other essential study documents
• Manage study conduct, ensuring that operating procedures and company policies are followed and that trials meet all applicable Regulations and Guidelines required for testing investigational and/or marketed devices
• Responsible for the selection of Contract Resource Organizations (CRO) and oversight of contracts, timelines, and budgets, when applicable
• Contribute to the improvement of clinical trial processes, including benchmarking and maximizing across other J&J companies
• Other related duties as assigned by management

Qualifications:

• Bachelor of Science or equivalent degree
• 5+ years’ experience in Clinical Research in a medical device or pharmaceutical regulated industry
• Must have a minimum of 2 years’ experience as a clinical research associate
• Complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP)
• Strong communication, organizational and interpersonal skills
• Basic understanding of diverse areas of business (e.g., R&D, Operations, QA, laboratory, regulatory, project management, etc.)
• Ability to effectively work with a team and influence peers, affiliates and Regulatory agencies (primarily IRBs/Ethics Committees) to ensure that regulatory and business needs are met

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is:

$105,000-$-165,000

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.