Research Quality Assurance Coordinator

Retina Consultants of Texas; San Antonio (TX); On-site; USD 55,000 - 85,000; Full time

Job summary

Retina Consultants of Texas is seeking a Quality Assurance Coordinator to visit multiple research sites and conduct QA activities to ensure study integrity and patient safety.

You will effectively communicate findings to site staff and stakeholders, drive process improvements per ICH/GCP and FDA guidelines, coordinate training workshops, travel to clinics as needed, and maintain thorough QA records and audit trails. Strong attention to detail and excellent documentation skills are essential.

Qualifications

• 1–2 years of experience as a research assistant or research coordinator.
• Knowledge of ICH/GCP and FDA regulations.
• Attention to detail and ability to multi-task.
• Strong verbal and written communication skills.
• Bachelor’s degree preferred or equivalent experience.

Responsibilities

• Screening visit reviews to ensure compliance with protocol and GCP.
• Conduct Site Initiation Visit (SIV) checks before study trial completion.
• Verify documents and trainings are completed per SIV process.
• Manage QA check visit schedule and assign observers.
• Communicate QA check reports to necessary parties.
• Coordinate and deliver QA-related training workshops.
• Travel to all research sites to conduct QA checks.

Skills

Attention to detail

Multi-tasking

ICH/GCP FDA regulations

Communicate findings clearly

Verbal and written communication

Education

High School diploma or equivalent

Bachelor’s degree preferred

Job description

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

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