Clinical Research Coordinator, QA

Job#: 3041298

Job Description:
Clinical Research Coordinator, QA

Location: Burlingame, California

Role Overview

A Health Technologies team is seeking a Clinical Research Coordinator to support data collection and study execution in a lab and clinical research organization (CRO) environment. This role will partner with multidisciplinary stakeholders to plan and execute research and validation studies for novel health technology approaches. The ideal candidate can manage multiple aspects of research operations, including coordination with internal teams, as well as external partners such as vendors and academic collaborators.

Key Responsibilities

• Coordinate clinical technology validation studies, including operational planning and day-to-day management of research execution.
• Serve as the primary point of contact for research participants, vendors, and CRO partners, coordinating studies from startup through close-out.
• Manage data collection and processing, maintain research project databases, and develop flow sheets and other relevant study documentation.
• Maintain research schedules and communicate study milestones, risks, and reporting updates to the research team and key stakeholders.
• Assist the research team with Institutional Review Board (IRB) submissions and ongoing compliance management.
• Align operational aspects of research with engineering, legal, product, and quality requirements.
• Assist with the assessment and implementation of new processes to improve study setup, administration, and execution efficiency.
• Provide on-site technical and quality assurance support at the CRO for sleep study execution, including device preparation and study-readiness checks.
• Support on-site firmware and software updates, including quality checks on new software versions.
• Troubleshoot live study sessions, triage technical and operational issues, and coordinate timely escalation to the appropriate internal teams.
• Perform data quality spot checks and help identify issues that may impact study integrity or participant experience.
• Travel to the CRO site when requested to support study setup, live-session execution, troubleshooting, and quality assurance activities.

Required Qualifications

Education: Bachelor's degree or higher in a field requiring significant human subjects research experience.

Experience: 2+ years of experience with clinical research in an academic and/or commercial setting, with an understanding of the study lifecycle and clinical research ecosystem. 2+ years of experience working with multidisciplinary stakeholders such as research scientists, statisticians, product managers, and software engineers.

Skills: Strong knowledge of, and proficiency in navigating, sensitive issues related to human subjects research and clinical research in digital health. Technical expertise in study startup, human subjects enrollment, consenting, data collection, and data management. Experience supporting device preparation, firmware/software updates, issue triage, and data quality review in a clinical research or digital health environment. Ability to travel to CRO sites as requested.

Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.

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Everforth Apex Benefits Overview: Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Everforth Apex team member can provide.

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