Research Quality Assurance Coordinator

Overview

 Job Summary:

The Quality Assurance Coordinator will be tasked with visiting multiple Research sites and conducting QA activities. The coordinator will be responsible for effectively communicating findings to the right people in an effort to drive process improvement as it relates to the study trial

Responsibilities

Duties and Responsibilities:

• Conducts screening visit reviews as part of the patient intake process to ensure compliance with GCP and study protocol requirements  
• Conducts SIV (Site Initiation Visit) check before a study trial is completed at the clinic site.
• Ensures documents and trainings are completed as part of the SIV process
• Conducts Quality Assurance checks to include managing the schedule of the QA check visits, who will conduct the visit, shadow employees as part of the QA check.
• Completes and communicates QA check report to necessary parties
• Helps coordinate training workshops related to quality assurance
• Partners with trainers regarding training content related to findings in the QA process
• Assists lead trainer in preparation and delivery of training workshops not related to QA initiatives
• Facilitates trainings as needed
• Assists coordinators as needed to monitor and scrub charts
• Travels to all research sites to conduct QA checks

Skills/Competencies:

• Attention to detail
• Ability to multi-task
• Working knowledge of ICH/GCP and FDA regulations
• Ability to effectively communicate findings to all staff levels with the intent to bring value
• Excellent verbal and written communication skills

Qualifications

Education Requirements:

• High School diploma or equivalent required
• Bachelor’s degree preferred, experience in lieu of education will be accepted

Experience Requirements:

• 1-2 years of experience as a research assistant or research coordinator preferred