Mindlance · 2 weeks ago
User Study Researcher I
Cupertino, CA
Full-time
Onsite
Mid Level
3+ years expMindlance is seeking a User Study Researcher I to assist in managing user studies in health, fitness, wellness, and safety. The role involves documentation, training, operational management, and ensuring compliance with protocols while overseeing participant operations and data workflows.
Human Resources
Responsibilities
Documentation
Work with project leads to gather data and testing requirements from populations of interest. Maintain these documents during the study (e.g. manage amendments, etc)
Review and understand study protocols, inclusion/exclusion criteria, and study procedures
Create and maintain protocols, ICFs, study standard operating procedures/manual of operations, and other study-related documentation. Assist with document preparation and submission to IRB/Ethics Committees
Ensure appropriate compliance with relevant study protocols; Document protocol deviations and report serious adverse events (SAEs)
Training
Develop and train study personnel on data collection procedures, use of study systems and data monitoring processes
Ensure all required training documentation is up to date
Train study partners/vendors on the study protocol & SOPs
Equipment Readiness
Order/procure, gather devices, coordinate, distribute, and support other procurement activities
Install software and data collection apps as relevant on study devices, prepare devices between participants (if necessary)
Maintain study equipment and devices inventory
Coordinate hand off for testing
Manage inventory (including management of device software and applications, tracking what devices are used in which studies, etc)
Ship devices, if needed
Operational Management
Independently run and manage user studies in the health, fitness, wellness, and/or safety space. Initiative to self-start and motivation to improve user studies is a must. Optimally they could carry out the full life cycle of high impact research - including designing protocols, selecting and managing vendors, developing enrollment & throughput plans, executing data collection efforts, and analyzing study data in a timely and cost effective manner
Support the development, and implementation of, and management of the site-specific operational plan, timelines, and milestones
Oversee daily study workflow, ensuring participant visits, data collection, and sample processing run smoothly
Assist with basic data processing and data visualization as needed
Manage vendors or academic partners to execute studies correctly, on-time, and on-budget
Identify and resolve risks to schedule and data quality
Quality Management/Support
Ensure all site operations comply with IRB approvals, study protocols, Good Clinical Practice (GCP), HIPAA, and institutional requirements
Support in the development of, and implementation of quality control processes for data accuracy and protocol adherence
Work closely with scientists and researchers to monitor data, identify issues, and drive mitigations and fixes
Participant Operations Management/Support
Oversee recruitment and retention strategies to meet enrollment goals
Ensure participant scheduling, visit flow, and follow-up communications are well-coordinated
Monitor participant feedback and address operational issues impacting retention or satisfaction
Data & Sample Workflow Management/Support
Oversee data entry processes, ensuring timeliness, completeness, and accuracy
Review and approve of workflows for sample labeling, storage, and shipment according to protocol
Coordinate periodic data reviews and resolve operational discrepancies
Team & Resource Coordination/Support
Lead weekly team meetings to review progress, challenges, and next steps
Manage study budget at the site level, including tracking expenses and resource allocation
Maintain study inventory and oversee equipment procurement to prevent operational delays. Additional activities may include management of device software and applications, managing preparation of devices, installing software and data collection apps as relevant on study devices, and troubleshooting device issues as needed
Reporting & Communication Management/Support
Initiate, execute, and report status with keen focus on data quality and schedule
Track and report study progress & key performance metrics including recruitment rates, bins, data yield, data usability, visit completion, and protocol deviations
Manage and communicate project status with cross-functional teams and external vendors
Prepare operational updates for investigators, sponsors, and other stakeholders
Support preparation of interim and final study reports
Study Closeout Activities, if needed
Coordinate participant completion/early termination procedures
Finalize all data collection and resolve outstanding queries
Participate in study closeout activities, as needed
Complete final study reports and documentation
Other Tasks
Maintain study calendars and milestone tracking
Manage study budgets and review invoices if needed
Update study team on protocol amendments and study-related changes
Balance multiple projects if needed
Qualification
Required
Highly organized, ability to juggle multiple priorities at a time
Demonstrated ability to execute engineering research projects of varying sizes, manage timelines, and budgets
Excellent organizational, problem-solving, and communication skills
Problem solving skills to troubleshoot hardware and software challenges; analyzes engineering data to make study-level recommendations
Self directed, analytical and ability to collaborate in a team environment
Strong written & verbal communication skills; able to communicate effectively with various audiences
Ability to quickly learn new software applications, processes for data collection and upload and study devices
Thrives by managing fast paced projects with minimal direction
Track record of managing vendors or contractors to deliver timely results
Experience with clinical and/or medical device research
Bachelor's degree in health sciences, biomedical engineering, public health, project management, or related field
3+ years of experience managing or coordinating human health research studies, engineering operations, or relevant medical / clinical experience
Must have 2+ years of experience directly supporting technical operations in a research setting
Strong knowledge of GCP, HIPAA, and IRB processes
Preferred
Master's degree in health sciences, biomedical engineering, public health, project management, or related field
Advanced degree or experience analyzing engineering data is a plus, but not required
Company
Mindlance
Mindlance is a Staffing and Recruiting company which provides multi-vertical staffing services
1001-5000 employees
H1B Sponsorship
Mindlance has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (71)
2024 (53)
2023 (37)
2022 (72)
2021 (36)
2020 (40)
Funding
Current Stage
Late StageLeadership Team
R
Rajat Paul Dhall
Co-Founder & Managing Director
V
Vik Kalra
Co-Founder and Managing Director
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