Study Proctor

Documentation User Studies Research CoordinatorThe Study Proctor will support the following responsibilities: Draft Protocol & ICF using the Data Collection Requirements doc for the study, and maintain these documents during the study (e.g. manage amendments, etc) Review and understand study protocols, inclusion/exclusion criteria, and study procedures 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) Develop & maintain study standard operating procedures/manual of operations Training Ensure all required training documentation is up to date Training sessions with study partners Equipment Readiness Procurement, gather devices, and support procurement activities if needed Install software and data collection apps as relevant on study devices, prepare devices between participants (if necessary) Maintain study equipment and devices inventory Coordinate handoff for testing Inventory Management (including management of device software and applications, tracking what devices are used in which studies, etc) Shipping devices, if needed Operational Management/Support Support the development, implementation, 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 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. 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 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 Track and report study progress & key performance metrics, including recruitment rates, bins, data yield, data usability, visit completion, and protocol deviations. Prepare operational updates for investigators, sponsors, and institutional leadership. Support the 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 the study team on protocol amendments and regulatory changes Key Qualifications Highly organized, ability to juggle multiple priorities at a time Demonstrated ability to manage timelines, budgets, and multi-person teams. Excellent organizational, problem-solving, and communication skills. Problem-solving, debugging skills, and laser attention to detail Self-directed, analytical, and able to collaborate in a team environment Strong 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 Education & Experience Bachelor’s degree in health sciences, public health, project management, or related field (Master’s preferred). 3+ years of experience managing or coordinating human health research studies. Strong knowledge of GCP, HIPAA, and IRB processes. Preferred Skills Certification in Clinical Research Coordination (CCRC) or Clinical Research Associate (CCRA). Experience with electronic data capture (EDC) systems and clinical trial management software. Background in observational or interventional human health studies. Experience with wearables and health software Intermediate data analysis & statistical skills Job Type: Contract Pay: $53.00 - $68.00 per hour Benefits: 401(k) Dental insurance Health insurance Vision insurance Work Location: In person