[Remote] Senior Clinical Research Scientist: contact lenses

Note: The job is a remote job and is open to candidates in USA. Kelly Science & Clinical is seeking a Clinical Research Scientist for a direct-hire position at a cutting-edge client in the Oakland, California area. The role involves managing advanced clinical research studies for product development initiatives in the contact lens industry. Responsibilities • Plans and manages all aspects of clinical evaluation of product performance, including study design, clinical protocol writing, clinical study execution, performing or oversight of statistical analysis, clinical report writing, results delivery and participation in R&D technical teams, under direction of clinical management. • Coordinates standardized clinical protocol execution with established clinical research centers. • Strong research design knowledge, hypothesis testing and technical communication. • Aware of literature and other knowledge related to contact lenses. • Aware of basic regulatory requirements related to medical devices (GCP/ IRB / Design Control/ FDA & ISO standards/ EU MDR, etc.) and applies knowledge under direction of clinical management. • Conducts basic clinical assessments; serves as Sub-Investigator under direction of Principal Investigator. • Actively apply learnings from prior experience, current trends in clinical research, and competitor awareness to product development activity and/or invention applications; publishes or presents in scientific forums as needed. Skills • Manage advanced clinical research studies for product development initiatives in the contact lens industry. • Plans and manages all aspects of clinical evaluation of product performance, including study design, clinical protocol writing, clinical study execution, performing or oversight of statistical analysis, clinical report writing, results delivery and participation in R&D technical teams, under direction of clinical management. • Coordinates standardized clinical protocol execution with established clinical research centers. • Strong research design knowledge, hypothesis testing and technical communication. • Aware of literature and other knowledge related to contact lenses. • Aware of basic regulatory requirements related to medical devices (GCP/ IRB / Design Control/ FDA & ISO standards/ EU MDR, etc.) and applies knowledge under direction of clinical management. • Conducts basic clinical assessments; serves as Sub-Investigator under direction of Principal Investigator. • Actively apply learnings from prior experience, current trends in clinical research, and competitor awareness to product development activity and/or invention applications; publishes or presents in scientific forums as needed. • Research design, statistical analysis, medical writing, GCP and Design Control knowledge. • Understand biological and optical contributors to contact lens safety and performance. • Attention to detail, systematic and orientation toward careful meticulous work. • Excellent communication skills, both verbal and written, including appropriate use of medical and scientific terminology. • Ability to quickly assimilate and apply new information. • Working knowledge of computer operating systems. • Strong Excel database skills. • Well-organized, ability to multitask and adjust to changing priorities. • Minimum 2-years’ experience in contact lens or medical device industry required. • (OD or equivalent + MS) or (OD or equivalent + 2 years) or (PhD + 2 years). • Optometry/ Ophthalmology knowledge and experience desirable. • Clinical or Research degree in Vision Science or Visual Optics or Physiological Optics, or Optometry/ Ophthalmology highly preferred. • Clinical licensure in CA desirable, but not mandatory. Company Overview • Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom. It was founded in 1946, and is headquartered in Troy, Michigan, USA, with a workforce of 5001-10000 employees. Its website is https://set.kellyservices.us/. Apply tot his job Apply To this Job