Quality Assurance Auditor-Clinical Research

ABOUT CLIANTHA

Cliantha Research is one of the fastest growing Clinical Research Organization (CRO) in north America, stemming from our decades of experience in Asia and Europe.

We provide comprehensive and integrated offerings in Early Phase, Late Phase, Respiratory, Dermatology, Consumer Research, Research Lab, IVRT, Biometrics, Pharmacovigilance & Medical Services, and Environmental Exposure Chambers (EECs).

THIS POSITION IS A IN-PERSON POSITION LOCATED IN SAINT PETERSBURG FLORIDA

WHAT YOU WILL BE DOING:

This is a key role in the success of our organization, and as a Quality Assurance Auditor, your main function is to conduct routine internal audits of projects conducted at the site as scheduled. These audits are intended to assess Cliantha Research site’s compliance with Good Regulated Practices (GxP), Quality System Documents (such as SOPs), study protocols, pertinent industry regulations and guidelines; they include, but are not limited to, the following:

• Pre-study (documentation) audits
• In-process (procedures and documentation)
• Post-study (documentation) audits
• Statistics and/or pharmacokinetics
• CDISC audits
• Trial Master File audits

WHAT YOU MUST BRING TO BE THE SUPERHERO WE NEED:

• Minimum of Bachelor of Arts or Science Degree in a related field or sufficient equivalent relevant training and experience as judged by the site QA management.
• A minimum of one year experience in a Quality auditing role or equivalent clinical experience in the clinical research industry
• Expert knowledge of, and remaining current with, regulatory requirements pertaining to clinical and/or pre-clinical research (HPFB, FDA, EMA, MHRA, as well as GCP, GxP, etc.)
• Excellent organizational skills, detail oriented, efficient and able to multi-task and prioritize effectively.

Job Type: Full-time

Pay: $55,000.00 - $60,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Experience:

• Clinical trials: 2 years (Required)
• GCP: 2 years (Required)
• GDP: 2 years (Required)

Work Location: In person