Clinical Affairs Specialist

Clinical Affairs Specialist (CAS)

Direct Hire. Medical Device.

Santa Ana, CA. 70-95k

Talentry is looking for a Clinical Affairs Specialist (CAS) to manage the internal biocollection program and to support external clinical studies. To manage the internal biocollection team, he or she will draft protocols, maintain IRB approvals, collect and manage samples, and maintain records. To support external clinical studies, he or she will work closely with the internal team and the CROs to organize records and documents, manage devices and supplies, and facilitate all the clinical studies in compliance with Good Clinical Practices (GCP).

This person will ensure that the studies are done in a timely and effective manner, maintaining the PHI information, safeguarding the samples, and ensuring records and documents are accurate, timely, and appropriately accessible.

Requirements

BS in health, life-science, or nursing discipline and 4+ years of experience.

Proven experience conducting clinical studies.

Proven GCP/FDA/ICH guideline experience.

Attention to detail, organization, and the ability to dynamically prioritize are key traits.

Excellent communication and documentation skills.