Austin Retina Associates
AustinRegulatory Affairs Quality Coordinator I
Austin Retina Associates, Austin, Texas, us, 78716
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.
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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.
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