Clinical Affairs Specialist

1 week ago


Irvine, California, United States Fluxergy Europe gmbh 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. Our platform enables molecular, clinical chemistry, immunoassay, and hematology testing on the same system, making it a game-changer in the industry.

Our Mission

We are committed to decentralizing traditional laboratory infrastructure and making laboratory testing more accessible and efficient. Our team is passionate about developing cutting-edge solutions that meet the needs of our customers.

About the Role

We are seeking a highly motivated and detail-oriented individual to join our team as a Clinical Affairs Specialist. In this role, you will be responsible for ensuring that our processes, procedures, and products meet ISO13485 and FDA requirements. You will work closely with our Regulatory, R&D, and Logistics teams to ensure effective coordination and compliance.

Key Responsibilities:
  • Conduct on-site and remote monitoring activities for external clinical studies, including site enrollments, site management, interim and closeout visits.
  • 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.
  • Manage IRB activities, including submissions, amendments, continuing review reports, and document expiration notifications.
  • Ensure compliance of clinical studies with regulatory requirements, GCP guidance, and company policies.
  • Establish biocollection protocols, manage biocollection program, and maintain associated program records to support R&D.
  • Safeguard clinical samples, data, and records, ensuring confidentiality, integrity, security, and PHI protection.
  • Maintain regulatory, legal, and financial disclosure documents.
  • Support regulatory inspection activities as needed.
Requirements:
  • At least 5 years of managing clinical studies.
  • Experience collaborating with Regulatory, R&D, Operations personnel, and CROs.
  • Knowledge of Good Clinical Practice (GCP) guidelines and IRB activities (submissions, amendments, reviews).
  • 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.
What We Offer

We offer a competitive salary of $150,000-$165,000, as well as a comprehensive benefits package, including medical, dental, and vision insurance, 15 paid vacation days, 2-week paid winter break, 7 company-paid holidays, and 5 paid sick days. We are an equal opportunity employer and participate in the E-Verify program.



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