Round Rock -Clinical Research Coordinator I

Posted 3 Days Ago
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Round Rock, TX, USA
In-Office
Entry level
Professional Services
The Role
Coordinate and manage ophthalmology clinical trials including patient screening, consent, study visits, diagnostic imaging, data entry in EDC systems, regulatory documentation, sponsor/CRO communications, and monitoring support while maintaining GCP and protocol compliance.
Summary Generated by Built In

Clinical Research 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. Austin Retina Associates is seeking a responsible, self motivated, individual to provide research coordination in a thriving retina practice’s growing research department. Our ideal candidate is passionate about patient care and the administrative aspects of clinical research.

Duties/Responsibilities
  • Performs required trainings and obtains applicable certifications necessary to participate  in specific study protocols including GCP, IATA, and other protocol-specific training
  • Facilitates and coordinates daily clinical trial activities
  • Primary coordinator on 1+single site studies within the practice
  • Ensure study staff are trained on study protocols, ICF, manuals and document all trainings
  • Will create, manage and maintain source documents for each assigned trial
  • Attend teleconferences and meetings as requested by research manager
  • Review and understand all study protocols including proceedings, timeline, inclusion/exclusion criteria, confidentiality and privacy protections
  • Provide care for study patients during visits, perform diagnostic testing, 

schedule appointments and educate patients regarding retinal condition, available treatment 

options and details of study protocol

  • Preview with patient the involvement of potential study and complete both physician and patient consent
  • Provide ongoing communication regarding study to patient’s physicians
  • Perform data entry in multiple Electronic Data Capture, EDC, systems
  • Primary contact for monitor site visits, preparing documentation, and making corrections to meet requirements and deadlines as needed
  • Communicate and coordinate with study sponsor, monitors, and CRO’s including data entry queries, audits and monitoring visits
  • Performs multiple imaging procedures required for specific study protocols; to be certified in digital imaging reading centers as utilized by each study sponsor
  • Manages and maintains all regulatory information about the study including protocols, investigator brochure, IRB documents, Investigator disclosures, CVs, training, documentation, instructions and reporting requirements for the IRB and the sponsor
  • Collects updated medical history, ALL adverse and serious adverse events  and reports to the sponsor and IRB within the required timeframes
  • Screens patients for eligibility using protocol-specific inclusion and exclusion criteria, 

documenting each potential participant's eligibility accurately

  • Other duties assigned on an as needed basis delegated by study protocol or manager
Required Attributes
  • Perform multiple imaging procedures required for each specific study protocol with the intent to be certified through the digital imaging reading center utilized by each study sponsor
  • Train and certify to perform refraction and vision testing
  • Deliver safe and appropriate care to patients in addition to the requirements outlined in Study 

protocol, Good Clinical Practice (GCP) Guidelines, and Standard Operating Procedures (SOPs)

  • Ability and willingness to perform venipunctures and process samples with training provided
  • Master multiple computer systems including Google, MicrosoftOffice, Teams, data management 
  • Ability to develop and maintain strong relationships with physicians, coworkers, and patients 
  • Will master ophthalmology and retina terminology
  • ICH GCP Training/Certification
  • Certified Ophthalmic Assistant
  • Cooperates with supervisory staff, physicians, peers, external customers, and patients in a 

positive, energetic, and professional manner

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
  •  Bilingual in Spanish
  • Ophthalmic experience
  • Demonstrates high-level initiative and critical thinking skills 
  • College degree preferred, significant relevant experience, and/or Ophthalmic experience
  • CRA tier III and/or 18 months with prior performance review or assessment exceeding expectations 
  • Experience in the following is preferred but not required: FA, FP, FAF, and IR imaging on 

OIS/Topcon, Heidelberg and Optos, SD-OCT scanning on Heidelberg and Cirrus systems

  • CCRP  or CCRC Certification
  • Experience with Real Time CTMS
Position Details
  • Schedule approximately 8-5pm during weekdays 
  • Hourly pay, FLSA non-exempt, eligible for overtime

Physical Demands and 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 up to 40 pounds on occasion. Specific vision abilities required by this job includes 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.

Skills Required

  • Obtain protocol-specific trainings and certifications (including GCP and IATA)
  • ICH GCP Training/Certification
  • Certified Ophthalmic Assistant
  • Perform multiple ophthalmic imaging procedures and attain certification in digital imaging reading centers
  • Train and certify to perform refraction and vision testing
  • Ability and willingness to perform venipunctures and process samples (training provided)
  • Perform patient care during study visits and diagnostic testing per protocol
  • Maintain regulatory study documentation (protocols, IRB documents, investigator disclosures, CVs, trainings)
  • Perform data entry and manage queries in multiple Electronic Data Capture (EDC) systems
  • Master multiple computer systems including Google, Microsoft Office, Teams and data management tools
  • Ability to develop and maintain strong relationships with physicians, coworkers, and patients
  • Cooperate professionally with supervisory staff, physicians, peers, external customers, and patients
  • Ophthalmic experience (preferred)
  • Bilingual in Spanish (preferred)
  • CCRP or CCRC Certification (preferred)
  • Experience with Real Time CTMS (preferred)
  • Experience with FA, FP, FAF, IR imaging and SD-OCT on OIS/Topcon, Heidelberg, Optos, Cirrus systems (preferred)
  • College degree preferred or significant relevant experience (preferred)
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The Company
0 Employees
Year Founded: 1978

What We Do

Austin Retina Associates is committed to delivering excellence in retina care, treating everyone with respect and dignity. As the largest group of retina specialists in Greater Austin and Central Texas, they utilize cutting-edge technologies and state-of-the-art procedures at their retinal diagnostic centers to provide the best possible care for diseases involving the retina, vitreous, and macula, having been leaders in specialized retina care for over 40 years.

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