Staff Clinical Research Scientist
About The Position
We are searching for the best talent to join our Vision team as a Staff Clinical Research Scientist located in Irvine, CA or Milpitas, CA. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. 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. As a Clinical Scientist in the Surgical Vision platform, you will be part of a high-functioning team with core expertise in ophthalmology and medical device research. This role will particularly focus on supporting the J&J Vision Surgical Instrumentation platform of devices. You'll be an integral part of your cross-functional project teams, devising clinical strategy and delivering results that help create new products that drive the business. This role is best suited for clinically trained people who practice critical thinking, who are inventive, efficient and methodical, with a desire to work with industry leaders. This role will be responsible for conducting registered and non-registered clinical trials of products that have been determined to satisfy a medical need and/or offer commercial potential. You will oversee and interpret results of clinical investigations in preparation for marketing applications for software-driven medical devices/surgical instrumentation. You will provide scientific support in designing, conducting, monitoring, reporting and regulatory submission of clinical trials. You will play a key role in the review of the data for clinical trials, including reviews on eligibility, efficacy, safety, coding, protocol deviation, etc. Together with your team, you'll bring new technologies to doctors and their patients.
Requirements
- Bachelor’s degree in a scientific field is required
- At least 4 years of work experience in clinical or scientific research
- Strong background in ophthalmology, optometry, vision science & optics
- Strong writing ability
- Basic knowledge of statistics
- Proficient with computers and software, especially MS Word, Excel & PowerPoint
Nice To Haves
- Advanced degree is preferred (Doctorate in Optometry or MD or Ph.D. or equivalent)
- Experience in class II/III medical device research, specifically surgical instrumentation
- Solid understanding of industry, regulatory and compliance requirements, including medical device software
- Well-versed in delivering clear, concise written and verbal communication
- Work effectively as part of a cross-functional global team
Responsibilities
- Represent Clinical Science in cross-functional project team meetings, provide project team requirements as needed, with input/guidance from senior function members.
- Align with Clinical Operations team (study managers, CRAs) on project status/updates and identify issues or impact to project timelines as appropriate.
- Plan, design and develop/write documents required for clinical projects, including protocol outlines, protocol procedures, and reports.
- Draft, revise and perfect written materials in alignment with colleagues and partners to produce landmark scientific publications, including conference posters, KOL presentations, and technical or promotional documents.
- Operate in accordance with functional and enterprise SOPs, ensure training is complete and current.
- Evaluate and interpret clinical research data to ensure timely and accurate data analysis to be presented in a way that fairly and accurately reflects study results.
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 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
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- 10 days Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
- Consolidated retirement plan (pension)
- Savings plan (401(k))
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What This Job Offers
Job Type
Full-time
Career Level
Senior
