Clinical Research QA Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Create and uphold standard operating procedures (SOPs) for monitoring and quality management documentation.

• Perform quality assessments of monitoring reports, essential documents, and regulatory files.

• Monitor and confirm corrective and preventive actions (CAPA) and their effectiveness.

• Execute or assist with internal audits and activities related to inspection readiness.

• Provide training on Good Clinical Practice (GCP) and protocols for clinical research personnel.

⛳️ Requirements

• A bachelor's degree in a life science or a related discipline.

• QA certification (such as CQA or RQAP-GCP) is preferred.

• A minimum of 5 years of experience in quality assurance or clinical research.

• At least 3 years of experience in GCP quality functions for studies regulated by NIH or FDA.

• Excellent analytical, documentation, and communication abilities.

• Five or more years of relevant experience supporting clinical research programs regulated by NIH or FDA.

• Familiarity with Good Clinical Practice (ICH E6).

• Knowledge of 21 CFR Parts 11, 50, 54, 56, 312, and 812, as applicable.

• Understanding of 45 CFR Part 46 and HIPAA regulations.

• Current training in human subjects protections and GCP (for example, CITI or an equivalent program).

• Experience collaborating in a multidisciplinary team environment with Government clinical investigators, regulatory personnel, and program officials.

🏝️ Benefits

• Competitive salary rate.

• Various benefit options available.

• Commitment to equal opportunity employment.