Clinical Affairs Specialist

1 month ago

Irvine, United States DIALITY INC Full time
Job DescriptionJob Description

Job Title

Clinical Specialist

Department

Clinical Affairs

Hiring Manager Title

Associate Director, Clinical Affairs

Position Type

Exempt

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:

• 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 a 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

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