Clinical Affairs Specialist CAS

Clinical Affairs Specialist (CAS)

Direct Hire. Medical Device.

Santa Ana CA. 7095k

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 lifescience 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.

Benefits