Clinical Research Associate at Diality Inc in Irvine, CA

Description

Company & Job Overview:

The Clinical Research Associate (CRA) will support Clinical Operations in planning, coordinating, and executing Diality clinical trials in compliance with applicable regulations (e.g., FDA, ISO 14155, ICH-GCP). This position plays a key role in supporting research projects at Diality, combing 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 (e.g., medical affairs, field service, clinical operations, clinical training and support), and external partners (Contract Research Organization, vendors) to ensure the quality and integrity of clinical data while maintaining adherence to study timelines.

Responsibilities:

Clinical Trial Administration

• Assist with trial start-up, including preparing and submitting regulatory and ethics documents, such as IRB/EC submissions, contracts, and site feasibility questionnaires.
• Maintain and organize the Trial Master File (TMF) and ensure all essential documents are current, complete, and audit-ready.
• Track and manage trial documentation, including but not limited to site contracts, investigator agreements, financial disclosure forms, and training records.
• Monitor study progress by updating trackers and preparing study status reports for internal and external stakeholders.

Site Management & Communication:

• Establish, Monitor and Control tasks required tasks for site start-up activities during clinical trials.
• Facilitate Communication Plan for clinical trial sites, including communications for internal Diality support teams
• Act as a point of contact for clinical trial sites regarding study-related questions and issues.
• Assist in managing site readiness, including regulatory and ethics submissions as needed, contract negotiations, and training.
• Monitor site performance and compliance with protocols, regulations, and study timelines.
• Support site readiness by ensuring all required study materials, such as investigator site files and study binders, are prepared and distributed.
• Assist in scheduling and coordinating investigator meetings, site initiation visits (SIVs), and other study-related activities

Regulatory Compliance & Documentation:

• As needed, assist with timely and accurate submission of regulatory documents, including IRB/EC approvals and site files.
• Assist in writing and reviewing protocols, informed consent forms (ICFs), and other study-related documents.

Clinical Monitoring:

• Perform remote monitoring activities such as source data verification (SDV) and data entry checks.
• Assist with monitoring safety reporting, adverse events (AEs), and serious adverse events (SAEs).
• 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 (e.g., laboratories, CROs).
• Track study metrics, such as patient recruitment, site enrollment, and data collection timelines.

General Support:

• Schedule and organize internal and external meetings, including drafting meeting agendas and minutes.
• Assist in the preparation of presentations to both internal and external stakeholders as needed.
• Support audit and inspection readiness by ensuring proper documentation and compliance with company SOPs and regulatory guidelines.

Collaboration & Reporting:

• Collaborate with other Diality cross-functional teams, including regulatory, quality to ensure study compliance.
• Support data management activities with data cleaning and resolving queries as applicable.
• Prepare regular study updates, reports, and presentations for internal stakeholders.

Requirements

Required Skills & Abilities

• Attention to detail and problem-solving skills to ensure data quality and compliance
• Strong organizational and time management skills.
• Excellent written and verbal communication abilities.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to work independently and collaboratively in a fast-paced environment.

Education & Experience

• Bachelor’s degree in a life science, healthcare, or related field (e.g., biology, nursing, or biomedical engineering).
• 5+ years of clinical research experience at a Sponsor, preferably in medical devices. A combination of other relevant experience (e.g., site level/CRO research) may also apply.
• Familiarity with clinical trial regulations, including FDA, ISO 14155, and ICH-GCP.
• 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.

Salary Description

$120,000 - $135,000