Clinical Specialist

Company & Job Overview:

Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre-mixed dialysate bags or external water-treatment systems.

The Clinical Specialist is responsible for the co-ordination and implementation of clinical trials and studies, ensuring adherence to regulatory requirements and maintaining data integrity and patient safety standards. Additionally, this role carries cross-functional responsibilities that extend to commercialization efforts, bridging clinical development with market readiness and product launch strategies

Responsibilities:

​​​Provides guidance to teams within the scope of established company policies.

Lead comprehensive training programs for investigative sites, ensuring understanding and compliance with study protocols, procedures, and regulatory requirements.

Conduct hands-on training sessions, ensuring trial site personnel are well-versed on protocol design and proficient in device operation.

Lead ongoing training and support to sites throughout the duration of the clinical trials, addressing queries and conducting training sessions as needed.

Implement strategies for ongoing education and support, ensuring clinical trial site personnel remain updated on any potential design changes, software updates, and/or protocol revisions.

Collaborate with site staff to facilitate efficient patient recruitment and enrollment strategies, ensuring alignment with study timelines and goals.

Implement initiatives to overcome enrollment challenges, providing support and guidance to sites as needed.

Collaborate seamlessly across clinical trial activities and commercialization efforts to provide comprehensive support for the expanding organization.

Collaborate across departments, including Medical Affairs, Clinical Operations, Marketing, and R&D, to streamline efforts and enhance coordination.

Contribute to new product development within the organization through research and subject matter expertise.

Identify key product attributes for market expansion and new clinical applications, recognizing emerging opportunities driven by clinical needs.

Provide subject matter expertise for regulatory exchanges with medical societies, enhancing scientific communication.

Contribute to medical writing and educational activities, including abstracts, presentations, white papers, educational assets, the preparation of clinical documents, study design protocols, and other related tasks as required

Establish and maintain contacts with external partners such as university groups, KOLs, investigators, patient advocacy groups, industry groups, consultants, and other applicable medical professionals including Contract Research Organizations (CRO’s).]

Act as a clinical reviewer of advertising, promotional material, and upstream marketing escalation point for Diality, including but not limited to medical related questions/issues from Diality Sponsored projects.

Qualifications & Requirements:

Registered Nurse with a minimum of 5 years of clinical experience in nephrology with proven experience and proficiency across multiple care settings and modalities.

Possess working understanding of regulatory requirements in the medical device industry such as the Medical Device Directive 93/42/EEC, ISO 14155, and ICH guidelines

Possess the ability to ensure compliance throughout product development and launch.

Familiarity with Good Clinical Practices (GCPs) guiding clinical trial conduct.

Proven ability to collaborate across various departments, including engineering, marketing, and regulatory, to align clinical affairs with overall business objectives.

Demonstrates proficiency in both independent work and collaborative teamwork.

Enthusiastic about contributing to a dynamic fast-paced team, demonstrating adaptability, and a commitment to continuous learning and enhancement.

Possess excellent written and spoken communication skills.

Physical Demands:

​​Sustained periods of time standing and sitting in a laboratory​

Sitting at a desk utilizing a computer

Some lifting or moving of<25 pounds

Working Environment:

Ability to occasionally travel domestically and internationally