Clinical Research Associate (CRA)

ResMed • San Diego, CA

23h • $86,000 - $128,000

About The Position

The Medical Affairs team collaborates with the leaders of Sleep, Respiratory Care, SaaS, ResMed Healthcare, and Asia Growth Markets to ensure our work, especially our clinical research and market access projects, align with their strategic priorities. We also review key government policies, as part of the continuous evaluation and improvement process that helps us maintain global compliance across an ever-shifting landscape of legal and regulatory requirements. The two, research and compliance, work hand-in-hand, and when balanced properly allow us to generate important clinical, economic and market evidence, that improves the lives of patients in ways that are scientifically valid, clinically relevant and ethically sound. The primary role of the Clinical Research Associate is to support the planning, coordination, and execution of clinical research projects, including single- and multi-site clinical studies. The role has broad responsibilities across study operations, site coordination, EDC monitoring and data review, study documentation, participant and recruitment support, and cross-functional study activities.

Requirements

• Bachelor’s degree in life sciences, health sciences, public health, or a related field.
• Minimum of 2 years of experience in clinical research
• Experience in conducting medical device and/or in-vitro diagnostics studies preferred. Pharmaceutical background will also be considered
• Working knowledge of applicable clinical research regulations and standards, including ICH, GCP, FDA regulations, ISO standards, and HIPAA, as applicable.
• Proficiency in Microsoft Office applications (SharePoint, Word, Excel, PowerPoint, and Outlook)
• Experience with electronic data capture (EDC), clinical trial management, and other clinical research systems.
• Ability to use approved digital and AI-enabled tools to support documentation and meeting summaries, in accordance with company policies and data privacy requirements.
• Strong organizational, analytical, written, and verbal communication skills.
• Strong attention to detail and documentation, with the ability to manage multiple studies, priorities, and deadlines.
• Ability to work independently while collaborating effectively within cross-functional teams.
• Proactive, problem-solving mind set and self-motivated, with strong follow-through and accountability.
• Demonstrates integrity, sound judgment, and a strong team orientation
• Ability to work a flexible schedule as needed to support clinical study activities.
• Ability to work effectively with global, cross-functional teams across multiple time zones, including flexibility to attend occasional meetings outside standard business hours.

Nice To Haves

• Experience supporting medical device and/or in vitro diagnostic clinical studies; pharmaceutical clinical research experience will also be considered.
• CRA or clinical research certification (e.g., CCRA, CCRC, or CCRP).
• Current GCP certification.
• Clinical research or healthcare experience related to sleep and respiratory medicine.

Responsibilities

• Support the planning, start-up, execution, monitoring, and closeout of single- and multi-site clinical research studies.
• Participate in cross-functional team meetings in the planning and execution of clinical trials.
• Coordinate day-to-day study operations with internal teams, clinical sites, vendors, CROs, and contractors, including meeting support.
• Contribute to the development of study documents, including protocols, amendments, informed consent forms, CRFs, source documents, training materials, and study reports.
• Conduct site feasibility assessments and site selection activities.
• Conduct assigned EDC monitoring and centralized data review activities, including CRF review, query management, missing data follow-up, data reconciliation, and documentation of findings.
• Maintain study trackers, metrics, dashboards, screening and enrollment reports, query reports, timelines, and study summaries to support operational oversight and leadership updates.
• Track enrollment, retention, visit completion, study supplies, device accountability, protocol deviations, adverse events, technical observations/device deficiencies, audit findings, and other study issues.
• Collect, track, file, and reconcile electronic Trial Master File (eTMF) and site regulatory documents to support inspection readiness.
• Support preparation, tracking, and submissions to IRB and regulatory documentation, as assigned.
• Support approved recruitment activities, including recruitment campaigns coordination, prescreening activities, participant follow up, and scheduling appointments.
• Support research participant visits as needed, including visit preparation, documentation, data entry, and follow-up in accordance with the protocol and study procedures.
• Coordinate ordering, shipment, tracking, and reconciliation of study supplies and equipment, as applicable.
• Support Resmed Clinical Research Registry campaigns and assist with registry and database updates, as required.
• Develop study budgets and initiate clinical research agreements
• Support audit and inspection readiness activities, including document review, tracking, and follow-up of assigned action items.
• Contributes to the SOP review process and/or other Clinical Operations Initiatives
• Perform other duties and responsibilities as required to support clinical research activities and business needs.

Benefits

• comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance.
• Flexible Time Off (FTO)
• 11 paid holidays plus 3 floating days
• 14 weeks of primary caregiver or two weeks of secondary caregiver leave

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level