Our ever-evolving suite of health and wellness products are helping our users live more active, healthier lives. Be ready to make something great when you come here. Dynamic, inspiring people and innovative, industry-defining technologies are the norm at Apple. The people who work here have reinvented and defined entire industries with our products and services. The same dedication to innovation also applies to our approach to health - strengthening our commitment to leave the world better than we found it. 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.
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Description
Studies Specialists are responsible for capturing and organizing key information with a focus on understanding regulations requirements, how those apply to the study and the ability to synthesize and summarize the data for delivery to senior management. Studies Specialists must excel at multi-tasking while maintaining high-quality studies with external sites and vendors. Studies Specialists are key to managing the Good Clinical Practice (GCP) and document details required for a successful study, from requirements, to planning and implementing a strategic plan for GCP compliance and audit readiness. Some of the key responsibilities include: • Create, develop, review, and finalize study related documents such as operational plans, informed consent forms, etc. • Prioritize and be proactive with internal engineering development teams and external partners to achieve success with delivering data on time. • Interact with multi-functional teams, such as IRB, internal IRB, clinical compliance teams, regulatory and quality assurance teams, engineering design disciplines, data analysis, legal, and other project management teams. • Responsible for maintaining communication with external sites, tracking delivery and change control of documentation, and communication with internal collaborators. • Develop, update, and maintain clinical SOPs. • Maintain study TMF and ensure audit readiness. This is a site-based role. Some travel is required, approximately 15-20%.
Minimum Qualifications
- B.S. degree in biomedical engineering or any engineering field, or equivalent
- 5+ years of clinical research experience
- Strong human research background with clear understanding of study lifecycle
- Strong knowledge of domestic regulations
- Experience working with and managing cross functional teams, external sites and/or managing vendors
Preferred Qualifications
- 2+ years of project management experience
- Experience in R&D or consumer product development a plus
- Strong knowledge of International regulations
- Highly organized and hyper-attentive to detail
- Thrive in a fast-paced environment, is flexible and can respond quickly, energetically, and enthusiastically to changes.
- Ability to adapt, improve, and champion best practices
- Self-motivated and proactive with the critical thinking and resourcefulness to achieve study objectives
- Excellent verbal and written communication skills
Pay & Benefits
At Apple, base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role. The base pay range for this role is between $118,500 and $197,500, and your base pay will depend on your skills, qualifications, experience, and location.
Apple employees also have the opportunity to become an Apple shareholder through participation in Apple's discretionary employee stock programs. Apple employees are eligible for discretionary restricted stock unit awards, and can purchase Apple stock at a discount if voluntarily participating in Apple's Employee Stock Purchase Plan. You'll also receive benefits including: Comprehensive medical and dental coverage, retirement benefits, a range of discounted products and free services, and for formal education related to advancing your career at Apple, reimbursement for certain educational expenses - including tuition. Additionally, this role might be eligible for discretionary bonuses or commission payments as well as relocation. Learn more about Apple Benefits.
Note: Apple benefit, compensation and employee stock programs are subject to eligibility requirements and other terms of the applicable plan or program.
Apple is an equal opportunity employer that is committed to inclusion and diversity. We seek to promote equal opportunity for all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, Veteran status, or other legally protected characteristics. Learn more about your EEO rights as an applicant .
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