Clinical Research Scientist

Masimo•Irvine, CA

18h•$100,000 - $140,000

About The Position

The Clinical Research Scientist demonstrates significant scientific judgment in clinical research study protocol design using experience and expertise in research and literature review. This position leads and manages complex clinical research projects to support R&D efforts, regulatory filings, or marketing initiatives within Masimo Corporation. This position focuses on both Pre-Market and Post-Market Clinical Studies, with the primary objective of increasing Masimo’s ability to identify, analyze, and act on research information in order to demonstrate the safety and effectiveness of Masimo products, as well as improve customer satisfaction. This position must also ensure that all activities will be conducted in accordance with Government Regulations (FDA, EU MDR and International), Good Clinical Practices (GCP) and company Standard Operating Procedures (SOP).

Requirements

Extensive experience in clinical, medical or biological research, with strong emphasis on experimental design and analytical and statistical techniques;
Excellent understanding of Good Clinical Practice and Regulations;
Can communicate effectively in both written and spoken form to management and scientific circles;
Must be able to travel up to 25% of time, both domestically and internationally;
Must be able to lift and carry up to 20 pounds;
Advanced degree in science or engineering, preferably a PhD, is recommended. Bachelor’s degree, preferably in science or related field is minimally required.

Nice To Haves

Proven track record and experience in Clinical Research;
Proven track record in publication to medical, biological, scientific or public health journals;

Responsibilities

Demonstrates strong understanding of theory of operation and clinical performance of Masimo products and parameters, product development pipeline, therapeutic space, and business needs;
Retrieves and manages scientific references, and understands scientific content, experimental design, and analytical approaches used;
Utilizes advanced understanding of scientific goals, applies principles of clinical study design and research methodology to assigned research projects in alignment with departmental objectives to create protocols, plans, and strategies, etc. to evaluate clinical performance or acceptance of Masimo products both before and after product release;
Collaborates with investigators and research teams to gain input into study design, evaluate study feasibility, identify sites for study execution or data collection, and negotiate study budgets and contracts;
Develops clinical trial documents (e.g., study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochures with minimal direction;
Works as a skilled project manager who plans, implements and concludes complex clinical studies in support of major project timelines and market release goals, without supervision;
Works with internal stakeholders to develop studies that may lead to product improvements and increased customer satisfaction;
Works effectively in teams, successfully interacting with internal stakeholders (R&D, Marketing, Manufacturing, Regulatory, etc.) and external stakeholders (Customers, Investigators, Coordinators, CROs, etc.);
Ensures applicable trial registration from study initiation through posting of results and support publications as needed; (e.g., on www.clinicaltrials.gov)
Writes clear, succinct and detailed clinical study summary reports, citing appropriate literature, where applicable, and manages interactions with principal investigators in manuscript development and review;
Suggests improvement to departmental procedures for improved compliance to GCP;
Operates Masimo products and data acquisition systems for data collection at sites, as needed;
Manages all monitoring functions to ensure compliance to protocol, as needed;
Conducts moderate to advanced data analysis using spreadsheet and statistical programs, and organize reports of data in simple clear fashion with appropriate tables, charts and graphs;
Stays current with relevant medical literature in support of clinical use of Masimo products, and can assist colleagues from other teams with literature reviews and interpretations for product planning, development, and marketing;
Contributes to, or lead, the critical assessment and interpretation of published literature.
Acts a mentor, provides education and shares expertise to aid in career development of junior team members;
Ability to travel up to 25% of time, locally, domestically and internationally;
Works independently with limited supervision, depending on project/task complexity;
Performs special projects as requested.