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.

Let’s talk about 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 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.

Let’s talk about Qualifications and Experience

Required:

• 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.

Preferred:

• 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.

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.