Round Rock -Clinical Research Coordinator

Overview

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.

• 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.
• Serves as primary coordinator on one or more single-site studies within the practice.
• Ensures study staff are trained on study protocols, informed consent forms (ICF), manuals, and documents all trainings.
• Creates, manages, and maintains source documents for each assigned trial.
• Attends teleconferences and meetings as requested by the research manager.
• Reviews and understands all study protocols including proceedings, timeline, inclusion/exclusion criteria, confidentiality, and privacy protections.
• Provides care for study patients during visits, performs diagnostic testing, schedules appointments, and educates patients regarding retinal condition, available treatment options, and study protocol details.
• Previews with patients the involvement of potential studies and completes both physician and patient consent.
• Provides ongoing communication regarding the study to the patient’s physicians.
• Performs data entry in multiple Electronic Data Capture (EDC) systems.
• Acts as primary contact for monitor site visits, prepares documentation, and makes corrections to meet requirements and deadlines as needed.
• Communicates and coordinates with study sponsors, monitors, and CROs, 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 sponsor.
• Collects updated medical histories and documents adverse and serious adverse events and reports to the sponsor and IRB within required time frames.
• Screens patients for eligibility using protocol-specific inclusion and exclusion criteria and documents each potential participant's eligibility accurately.
• Other duties assigned on an as-needed basis delegated by study protocol or manager.

• Perform multiple imaging procedures required for each specific study protocol with the intention 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 the 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 Workspace, Microsoft Office, Teams, and data management tools.
• Ability to develop and maintain strong relationships with physicians, coworkers, and patients.
• 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.

• 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 the ability to independently manage workflow.
• Strong interpersonal skills including effective listening, clear communication, and effective customer problem resolution with a warm,…