Clinical Affairs Specialist

7 days ago


Irvine, California, United States Fluxergy Full time
About Us

Fluxergy is a rapidly growing in vitro diagnostics company that is revolutionizing laboratory testing with its innovative multi-modal point-of-care platform.

We're developing a game-changing platform that enables molecular, clinical chemistry, immunoassay, and hematology testing on the same system, with applications in the clinical, veterinary, and food safety industries.

Our company is built on a strong foundation of engineering, with a commitment to critical thinking and pragmatic problem-solving through a modular and systemic perspective.

We believe in the importance of transparent communication, flexibility, and a willingness to venture beyond familiar territories to achieve success.

About the Role

This is an exciting opportunity to join a small but passionate team at Fluxergy, where you will play a key role in ensuring our processes, procedures, and products meet ISO13485 and FDA requirements.

You will be responsible for conducting on-site and remote monitoring activities for external clinical studies, including site enrollments, site management, interim and closeout visits.

Additionally, you will manage deliverables from Regulatory, R&D, Logistics, and external CROs to ensure effective coordination, monitor the regulatory status of clinical studies, and mitigate GCP risks.

You will also be responsible for managing IRB activities, including submissions, amendments, continuing review reports, and document expiration notifications, as well as ensuring compliance of clinical studies with regulatory requirements, GCP guidance, and company policies.

Other key responsibilities include establishing biocollection protocols, managing biocollection programs, and maintaining associated program records to support R&D, safeguarding clinical samples, data, and records, and maintaining regulatory, legal, and financial disclosure documents.

What You'll Need to Have
  • At least 5 years of experience managing clinical studies
  • Experience collaborating with Regulatory, R&D, Operations personnel, and CROs
  • Knowledge of Good Clinical Practice (GCP) guidelines and IRB activities
  • Ability to organize and verify the accuracy and completeness of clinical study records and source data/documents
  • History of demonstrating study integrity by safeguarding clinical samples, data, and records
Our Benefits

We offer a comprehensive benefits package, including 99% medical benefit premiums, 100% dental and vision premiums, and 100% life insurance premiums, as well as 15 paid vacation days, 2-week paid winter break, 7 company paid holidays, and 5 paid sick days.

We are a flat organization by design, with many opportunities for career growth and professional development.

We are an equal opportunity employer and participate in the E-Verify program.



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