Clinical Research Associate (CRA)

ResMed is a mission-driven company focused on improving health and quality of life. The Clinical Research Associate supports the planning, coordination, execution, monitoring, and closeout of single- and multi-site clinical research studies, including site coordination, data review, study documentation, participant support, and cross-functional 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](https://www.resmed.com/en-us/sleep-health/resmed-clinical-research/) 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

Preferred

Experience in conducting medical device and/or in-vitro diagnostics studies preferred. Pharmaceutical background will also be considered

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

Medical device studies

In-vitro diagnostics studies

Pharmaceutical background

CRA certification

Clinical research certification

GCP certification

Healthcare experience

Sleep medicine experience

Respiratory medicine experience

Benefits

Employees scheduled to work 30 or more hours per week are eligible for benefits.

Comprehensive medical, vision, dental, and life insurance

AD&D insurance

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)

Tuition assistance

Flexible Time Off (FTO)

11 paid holidays plus 3 floating days

14 weeks of primary caregiver leave when welcoming new family members

Two weeks of secondary caregiver leave when welcoming new family members

Flexible work arrangements

The chance to learn from senior brand leaders

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.

Company

Sleep and breathing health devices and digital home care software

San Diego, California, USA

https://www.resmed.com.au/

Founded in 1989

5001-10000 employees

Qualifications

Bachelor's degree in life sciences, health sciences, public health, or a related field

Minimum of 2 years of experience in clinical research

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

Experience in conducting medical device and/or in-vitro diagnostics studies preferred. Pharmaceutical background will also be considered

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

Required skills

Clinical Research, Clinical Research Regulations and Standards, ICH Good Clinical Practice (GCP), FDA Regulations, ISO Standards, HIPAA, Medical Device Clinical Studies, Electronic Data Capture (EDC), Clinical Trial Management Systems, Microsoft Office

Preferred skills

Current GCP certification

Experience

2+ years