Clinical Research Associate

Responsibilities

• Aid in trial start-up by preparing and submitting regulatory and ethics documents.
• 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 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.
• Establish, monitor, and control tasks required for site start-up activities during clinical trials.
• Facilitate communication plans for clinical trial sites, including communications for internal Diality support teams.
• 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.
• Assist with regulatory compliance by assisting 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.
• 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.
• 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.
• Schedule and organize internal and external meetings, including drafting meeting agendas and minutes.
• Aid 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.
• 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

• 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.
• 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.

Salary

$120,000 - $135,000