Round Rock -Clinical Research Coordinator I

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. 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. 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 timeframes. 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. Required Attributes 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. 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 the ability to independently manage workflow. Strong interpersonal skills including effective listening, clear communication, and effective customer problem resolution with a 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 FA, FP, FAF, and IR imaging on OIS/Topcon, Heidelberg and Optos; SD-OCT scanning on Heidelberg and Cirrus systems is preferred but not required. CCRP or CCRC Certification. Experience with Real Time CTMS. Position Details Schedule approximately 8:00 am – 5:00 pm on weekdays. Hourly pay, FLSA non-exempt, eligible for overtime. Physical Demands 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 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. #J-18808-Ljbffr Austin Retina Associates