Posted: Dec 14, 2020
Weekly Hours: 40
The Health Technologies Group conceives of and proves out exciting new technologies for Apple’s future products and features. We are seeking a Studies Specialist to maintain our high standards with human study data collection efforts to support development and validation of new health sensors and algorithms.
- 4-7+ years of field clinical engineer or clinical research associate experience
- Strong human research background with clear understanding of study lifecycle for medical devices
- Highly organized and hyper-attentive to detail
- Thrive in a fast-paced environment
- Ability to adapt, improve, and champion best practices
- Self-motivated and proactive with the critical thinking and resourcefulness to achieve study objectives
- Excellent communication skills, both verbal and written
- Experience working with and managing external sites and/or managing vendors
- Some travel could be required, approximately 15-20%
Field Studies Specialists are responsible for designing and implementing the operational aspects of human subject research. They must be able to understand research goals and translate that to detailed documentation for execution by vendors & sites in the field. They must excel at planning at a detailed level in order to prepare test and study equipment, train vendor and site staff, manage device accountability, track data quality and manage corrective actions with vendors & sites. They love to maintain change control, adjusting the level of change control required depending on the needs for the study. Field Studies Specialists must excel at multi-tasking while managing multiple high quality studies with external sites and vendors.We are looking for someone who is flexible and can respond quickly, energetically, and enthusiastically to constant change. Cross-functional communication skills and experience are essential. Field Studies Specialists must be able to succinctly and accurately communicate results and requirements to all engineering design disciplines, data analysis, legal, business development, and other project management teams. Having exposure and familiarity with the changing dynamics of research and development is highly desired.
Education & Experience
- B.S. degree in biomedical engineering or any engineering discipline , or equivalent
- Background in Good Clinical Practice procedures