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User Study Researcher I
User Study Researcher IMindlance • Cupertino, CA
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User Study Researcher I

User Study Researcher I

Mindlance • Cupertino, CA
30+ days ago
Job type
  • Temporary
Job description

Key Qualifications
  • 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

Description
Responsibilities include:
  • Documentation Work with project leads to gather data and testing requirements from populations of interest. Maintain these documents during the study ( 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

Education & Experience
  • Bachelor’s degree in health sciences, biomedical engineering, public health, project management, or related field (Master’s preferred).
  • + years of experience managing or coordinating human health research studies, engineering operations, or relevant medical / clinical experience.
  • Must have + years of experience directly supporting technical operations in a research setting. Advanced degree or experience analyzing engineering data is a plus, but not required.
  • Strong knowledge of GCP, HIPAA, and IRB processes.

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User Study Researcher I • Cupertino, CA

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