Clinical Research Associate (CRA)

ResMed Inc; San Diego (CA); On-site; USD 86,000 - 128,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible work arrangements

Tuition assistance

Job summary

ResMed Inc invites applications for a Clinical Research Associate to plan, coordinate, and execute clinical studies, including single- and multi-site trials. You will support study operations, site coordination, EDC monitoring, data review, and regulatory documentation, collaborating with Medical Affairs, R&D, and external CROs.

The role requires a life sciences degree, 2+ years in clinical research, knowledge of ICH/GCP/FDA standards, and ability to work across time zones.

Qualifications

• 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.

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.

Skills

GCP knowledge

EDC monitoring

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor’s degree in life sciences

Tools

EDC systems

Microsoft Office

Job description

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.

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.

Qualifications and Experience

• 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.
• 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.

Computer Skills

• 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.

Qualifications

• 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.

At Resmed, you’ll be part of a mission driven company focused on improving health and quality of life. This role offers high visibility, the chance to learn from senior brand leaders, and the opportunity to shape how Resmed shows up across global markets. You’ll grow your skills in brand strategy, cross functional collaboration, and brand governance at scale. We are shaping the future at Resmed, and we recognize the need to build on and broaden our existing skills and continue to attract and retain the world’s best talent. We work hard to offer holistic benefits packages, provide flexible work arrangements, cultivate a workforce culture that allows employees to grow personally and professionally, and deliver competitive salaries to our team members. Employees scheduled to work 30 or more hours per week are eligible for benefits. This position qualifies for the following benefits package: 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. Employees receive Flexible Time Off (FTO), receive 11 paid holidays plus 3 floating days and are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members. Individual pay decisions are based on a variety of factors, such as the candidate’s geographic work location, relevant qualifications, work experience, and skills. At Resmed, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current base range for this position is: $86,000.00 - $128,000.00 USD Annual USD. Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates.

We commit to respond to every applicant.

Resmed (NYSE:RMD, ASX: RMD) creates life-changing health technologies that people love. We’re relentlessly committed to pioneering innovative technology to empower millions of people in more than 140 countries to live happier, healthier lives. Our AI-powered digital health solutions, cloud-connected devices and intelligent software make home healthcare more personalized, accessible and effective. Ultimately, Resmed envisions a world where every person can achieve their full potential through better sleep and breathing, with care delivered in their own home. Learn more about how we’re redefining sleep health at Resmed.com and follow @Resmed.