A minimum of a Bachelor's degree is required.
A minimum of 5 years of related work experience in auditing, clinical
operations, or other key related area
Knowledge of the drug development process, applicable regulations, R&D;
practices, and scientific and quality terminology.
Knowledge of Good Clinical Practices (GCP) and applicable
regulations/guidelines (e.g. FDA regulations, EU CTR, ICH E6 R2
Experience conducting Clinical Quality Assurance audits or assessments of
clinical investigator sites, studies, or systems
Understanding of fundamentals of clinical trial risk management.
Broad knowledge of management of standard operating procedures, good
documentation practices, and records management.
Digital literacy & Analytics - Experience using standard
applications/systems & data analytics tools.
Must be able to speak and write in English.
If you are under 18 years of age, you (the candidate) may need to obtain the
necessary working papers or other documentation required by state law to start the
assignment, as well as get a parent's consent for the background check.