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 clinicalstudies. To manage the internal biocollection team, he or she will draftprotocols, maintain IRB approvals, collect and manage samples, and maintain records.To support external clinical studies, he or she will work closely with theinternal team and the CROs to organize records and documents, manage devicesand supplies, and facilitate all the clinical studies in compliance with GoodClinical Practices (GCP).

This person will ensure that the studies are done in atimely 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 todynamically prioritize are key traits.

Excellent communication and documentation skills.

Benefits