Researcher / analyst
Position Location Irvine, California
Masimo (NASDAQ: MASI) headquartered in Irvine, California, is a fast-growing and award-winning international medical technology and device company with operations spanning the globe. We develop innovative, noninvasive monitoring technologies that save, extend and improve the lives of people of all ages, in all walks of life. These revolutionary technologies are helping to solve "unsolvable" problems that have plagued the healthcare industry, while taking the pain and discomfort out of blood monitoring. For more than 25 years, innovation has been and will continue to be our passion.
To learn more about us, please visit: www.masimo.com
The individual in this position is responsible for assigned clinical trial projects undertaken in support of a given product line or marketing initiative within Masimo Corporation. This includes the execution, and documentation of assigned clinical studies conducted to support R&D efforts, regulatory filings (510k or PMA), or marketing initiatives for Masimo products. Emphasis for this position will be placed on both Pre-Market and Post-Market Clinical Studies with the primary objective to increase Masimo's ability to act on research information in order to improve Masimo products. All activities will be conducted in accordance with Government Regulations (FDA, MDD and International), Good Clinical Practices (GCP), Standard Operating Procedures (SOP), and Masimo's guiding principles including Masimo's code of conduct and highest ethics.
This position will also be responsible for performing a wide variety of clinical laboratory tests on various biological specimens. Review, evaluate, document, and report results. Follow lab safety and maintenance protocols.
Duties & Responsibilities:
- Employ positive subject identification procedures to ensure the integrity of each specimen for pre-analytical, analytical, and post-analytical testing.
- Perform proper specimen collection, labeling, handling, preservation, processing, transportation, and storage of specimen.
- Review and evaluate the validity and accuracy of test results.
- Thoroughly document and communicate test results.
- Dispose of contaminated materials and equipment in accordance with policy and assure that work area is properly cleansed after each test.
- Responsible for a broad range of clinical trial duties, including equipment setup and operations, execution of studies according to test protocols/procedures and clinical work instructions, collect data, verify results and transfer data.
- May conduct more complicated studies, as well as contribute to study proposals, protocols, developing case report forms and other study related documents while applying principles of clinical study design and research methodology to assigned research projects when appropriate.
- Contribute, prepare and review study plans, contracts, budgets, informed consents, IRB submissions, case report forms (CRFs), and other study related materials to assure quality, consistency, compliance, organization, storage and accuracy across all assigned projects.
- Conduct site monitoring (qualification, initiation, monitoring and close out visits) to ensure and document site is trained to follow study procedures per test protocol(s).
- Monitor safety reviews and adverse event reporting for investigational medical devices to assure adherence to Good Clinical Practices (GCP), FDA and MDD regulations.
- Manage essential study documents to ensure they are properly organized and stored as quality/regulatory records.
- Create and maintain study planning tools including databases, study forms, and engineering data.
- Plan, implement, and conclude data collection for clinical studies in support of project timelines and market release goals with supervision.
- Perform compliance reviews on documentation of informed consent processes.
- Perform compliance reviews of subject study eligibility, including documentation of study-specific inclusion and exclusion criteria.
- Perform compliance reviews of subject study documents, monitoring the complete and accurate documentation of subject study data.
- Transcribe subject study data from paper source documents to EDC systems.
- Investigate and reply to data queries, in collaboration with relevant clinical team members when appropriate.
- Maintain and/or manage device accountability.
- Maintain and/or manage maintenance of equipment records and calibration records for equipment (including laboratory analyzers).
- Manage coordinating equipment and supplies necessary for clinical trials.
- May be required to travel based on business needs.
Minimum & Preferred Qualifications and Experience:
- Must be capable of interacting with all levels of management, coworkers, investigators, and subjects
- Demonstrate advanced judgement and decision making ability in the execution/oversight of clinical studies
- Ability to conduct basic data analysis using spreadsheets, preparing basic calculations, statistics, graphs, and tables
- Ability to write clear, succinct, and detailed clinical study and technical summary reports
- Experience working with various analytical instruments / laboratory techniques
- Familiarity with medical, pharmaceutical or medical device research
- Basic understanding of FDA Good Clinical Practice (GCP) guidelines for Medical Devices in conduct of clinical studies
- Experience in Post Market surveillance of Medical Devices and Regulatory Affairs submissions for new or modified devices desirable