Austin-Regulatory Affairs & Quality Coordinator I

Regulatory Affairs and Quality Coordinator I

Position Summary

Our goal is to advance retinal research, offer new treatment opportunities to our community, and provide the highest quality patient care. The Regulatory Affairs and Quality Coordinator I will assist with maintaining quality assurance processes related to clinical trials, ensure compliance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and company standards.

Duties/Responsibilities

• Will manage one to four Study Start-Ups at a time with minimal assistance
• Corresponds with Sponsors and Study Start-Up contacts
• Prepare regulatory study start-up documents and collect signatures to include FDA 1572, Financial Disclosure Forms, Protocol, and Investigator Brochure Signature Pages, etc.
• Coordinate with Local and Central IRBs/IBCs for initial study submissions
• Assists Coordinators with study start-up, ensuring timely completions
• May review and scrub subject binders prior to monitor visits
• Conduct internal audits of site staff, processes, and clinical trials
• Perform in-phase audits of study visits
• Review the Investigator Site File (ISF) for accuracy, timeliness, and completeness to facilitate site reconciliation of ISF contents to ensuring compliance with GCP/local regulations and organizational procedures
• Performs and documents QA monitoring activities via reports following the QA plan to note and track all observations, ongoing statuses, and assigned action items to resolution
• Assist Study Coordinators to conduct root cause analyses for quality issues and deviations
• Ensures timely follow-up and resolution of internal and external audit findings, CAPAs, and regulatory inspection observations
• Provides guidance towards audit readiness standards while supporting audit preparation and required follow-up actions
• Mentors, trains, and delivers training programs related to quality assurance, research administration and regulatory compliance while providing quality assurance support to clinical staff, investigators, and site personnel
• Will travel between ARA research sites
• Other duties assigned on an as needed basis delegated by Regulatory Affairs and Quality Manager and Research Director

Required Attributes

• Mastery level of medical, ophthalmology and clinical research terminology
• Strong understanding of GCP, ICH guidelines, and regulatory requirements
• Understands standards and timelines for own and others’ activities in the quality assurance and site team; able to quickly adapt to changing priorities to achieve goals / targets
• Familiarity with clinical trial management systems (CTMS)
• Master multiple computer systems including Google, Microsoft Office, Teams, and data management
• College degree or one-year ophthalmic regulatory affairs and quality experience
• COA

Preferred Attributes

• Demonstrated effectiveness showing courtesy, diligence, integrity, and teamwork in alignment with ARA core values
• Excellent organizational and time management skills ensuring all tasks are completed in a timely manner satisfactory to the organization with ability to independently manage workflow
• Strong interpersonal skills including effective listening, clear communication, effective customer problem resolution with warm encouraging demeanor
• Demonstrates high-level initiative critical thinking skills
• Experience in a retina clinic setting
• Experience within patient-oriented research clinical setting

Position Details

• Schedule 8-5 pm during weekdays
• Hourly pay, FLSA non-exempt, eligible for overtime

Physical Requirements

Prolonged standing and walking, some sitting, talking, and hearing both in person and by telephone; use hands to finger, handle and feel objects or controls; reach with hands and arms. Regularly required to stoop, kneel, bend, crouch and lift to forty pounds on occasion. Specific vision abilities required by this job include viewing multiple computer screens, close vision, distance vision, depth perception, color vision and the ability to adjust focus. Viewing images and operating computer devices constantly.