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.

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.

• 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