AustinClinical Research Coordinator I

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. Ensures study staff are trained on study protocols, ICF, manuals and documents all trainings. Creates, manages and maintains source documents for each assigned trial. Attends teleconferences and meetings as requested by research manager. Reviews and understands all study protocols including procedures, 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 details of study protocol. Previews with patient the involvement of potential study and completes both physician and patient consent. Provides ongoing communication regarding study to patient's physicians. Performs 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. Communicates and coordinates with study sponsor, monitors, and CROs including data entry queries, audits and monitoring visits. Performs multiple imaging procedures required for specific study protocols; will 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 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, Microsoft Office, 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 8‑5 pm 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 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