Clinical Research Associate

Clinical Research Associate (CRA)

The Clinical Research Associate (CRA) will support Clinical Operations in planning, coordinating, and executing Diality clinical trials in compliance with applicable regulations. This position plays a key role in supporting research projects at Diality, combining responsibilities of site management and administrative trial support to ensure smooth and efficient study operations.

As applicable, the CRA position works closely with clinical sites, internal departments, and external partners to ensure the quality and integrity of clinical data while maintaining adherence to study timelines.

Clinical Trial Administration

• Assist with trial start-up, including preparing and submitting regulatory and ethics documents.
• Maintain and organize the Trial Master File and ensure all essential documents are current, complete, and audit-ready.
• Track and manage trial documentation.
• Monitor study progress by updating trackers and preparing study status reports.

Site Management & Communication

• Establish, monitor and control tasks required for site start-up activities during clinical trials.
• Facilitate communication plan for clinical trial sites.
• Act as a point of contact for clinical trial sites regarding study-related questions and issues.
• Assist in managing site readiness.
• Monitor site performance and compliance with protocols, regulations, and study timelines.
• Support site readiness by ensuring all required study materials are prepared and distributed.
• Assist in scheduling and coordinating investigator meetings, site initiation visits, and other study-related activities.

Regulatory Compliance & Documentation

• Assist with timely and accurate submission of regulatory documents.
• Assist in writing and reviewing protocols, informed consent forms, and other study-related documents.

Clinical Monitoring

• Perform remote monitoring activities such as source data verification and data entry checks.
• Assist with monitoring safety reporting, adverse events, and serious adverse events.
• Support quality assurance efforts by identifying protocol deviations and ensuring corrective actions.

Study Support

• Participate in the development of study tools, training materials, and site binders.
• Assist in vendor and contract management for study-related services.
• Track study metrics.

General Support

• Schedule and organize internal and external meetings.
• Assist in the preparation of presentations to both internal and external stakeholders.
• Support audit and inspection readiness.

Collaboration & Reporting

• Collaborate with other Diality cross-functional teams.
• Support data management activities.
• Prepare regular study updates, reports, and presentations for internal stakeholders.

Required Skills & Abilities

• Attention to detail and problem-solving skills.
• Strong organizational and time management skills.
• Excellent written and verbal communication abilities.
• Proficiency in clinical trial management systems and electronic data capture systems.
• Ability to work independently and collaboratively.

Education & Experience

• Bachelor's degree in a life science, healthcare, or related field.
• 5+ years of clinical research experience at a Sponsor, preferably in medical devices.
• Familiarity with clinical trial regulations.
• Previous experience in a medical device company or knowledge of device-specific regulatory pathways.
• Experience with managing remote monitoring activities or decentralized clinical trials.
• Nephrology experience is a plus.

Travel

• This role is primarily office-based with occasional travel (up to 50%) to clinical sites and meetings as needed.