Clinical Research Associate (CRA)

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; Contribute 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

Requirements

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

Nice to have

Experience in conducting medical device and/or in-vitro diagnostics studies; Pharmaceutical background; Experience supporting medical device and/or in vitro diagnostic clinical studies; Pharmaceutical clinical research experience; 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

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); 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; Flexible work arrangements; Competitive salaries