Apply on Employer Site

Austin Retina Associates · 1 day ago

Austin-Regulatory Affairs & Quality Coordinator I

Austin, TX

Full-time

Onsite

Entry Level

1+ years exp

Austin Retina Associates is dedicated to advancing retinal research and providing high-quality patient care. The Regulatory Affairs and Quality Coordinator I will assist in maintaining quality assurance processes related to clinical trials while ensuring compliance with regulatory requirements and Good Clinical Practice guidelines.

Health CareMedicalProfessional ServicesService Industry

Growth Opportunities

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

Qualification

GCPRegulatory requirementsClinical trial management systemsMedical terminologyOphthalmology terminologyQuality assuranceInterpersonal skillsOrganizational skillsCritical thinkingTime managementTeamwork

Required

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

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