Research Quality Assurance Coordinator

Retina Consultants of Houston•San Antonio, TX

About The Position

The Quality Assurance Coordinator visits multiple research sites and conducts quality assurance activities. The role communicates findings to the appropriate people to support process improvement related to study trials. The coordinator reviews screening visits and site initiation processes for compliance, manages QA checks and reporting, and helps coordinate and deliver training. The role also assists coordinators with monitoring and scrubbing charts and travels to all research sites to conduct QA checks.

Requirements

High school diploma or equivalent required.
Working knowledge of ICH/GCP and FDA regulations.
Attention to detail.
Ability to multitask.
Ability to communicate findings effectively to staff at all levels with the intent to bring value.
Excellent verbal and written communication skills.

Nice To Haves

Bachelor’s degree preferred; experience in lieu of education will be accepted.
1–2 years of experience as a research assistant or research coordinator preferred.

Responsibilities

Conduct screening visit reviews as part of patient intake to ensure compliance with GCP and study protocol requirements.
Conduct Site Initiation Visit (SIV) checks before a study trial is completed at a clinic site.
Ensure documents and trainings are completed as part of the SIV process.
Manage the schedule of QA check visits and determine who will conduct each visit.
Shadow employees as part of QA checks.
Complete QA check reports and communicate them to the necessary parties.
Help coordinate training workshops related to quality assurance.
Partner with trainers on training content related to QA findings.
Assist the lead trainer with preparation and delivery of training workshops unrelated to QA initiatives.
Facilitate trainings as needed.
Assist coordinators as needed to monitor and scrub charts.
Travel to all research sites to conduct QA checks.