Position Summary
Austin Retina Associates seeks a Clinical Research Coordinator I to advance retinal research and provide new treatment opportunities to the community. The coordinator will support patient care and manage the administrative aspects of clinical research within a thriving retina practice.
Duties & Responsibilities
- Perform required trainings and obtain applicable certifications necessary to participate in specific study protocols (e.g., GCP, IATA).
- Facilitate and coordinate daily clinical trial activities and serve as primary coordinator on single‑site studies.
- Ensure study staff are trained on protocols, ICF, manuals and document all training.
- Create, manage and maintain source documents for each assigned trial.
- Attend teleconferences and meetings as requested by the research manager.
- Review and understand all study protocols including procedures, timeline, inclusion/exclusion criteria, confidentiality and privacy protections.
- Provide care for study patients during visits, perform diagnostic testing, schedule appointments and educate patients on retinal conditions, available treatments and study protocol details.
- Preview study participation with the patient and complete physician and patient consent.
- Maintain ongoing communication regarding the study with patient physicians.
- Perform data entry in multiple Electronic Data Capture (EDC) systems.
- Serve as primary contact for monitor site visits, preparing documentation and making corrections to meet requirements and deadlines.
- Communicate and coordinate with study sponsor, monitors and CROs, responding to queries and audits.
- Perform multiple imaging procedures required for specific study protocols and obtain certification through the digital imaging reading center utilized by each sponsor.
- Manage and maintain all regulatory information about the study, including protocols, investigator brochures, IRB documents, disclosures, CVs, training records and reporting requirements.
- Collect updated medical history, adverse and serious adverse events and report to sponsor and IRB within required timeframes.
- Screen patients for eligibility using protocol‑specific inclusion and exclusion criteria and document eligibility accurately.
- Complete additional duties as assigned by study protocol or manager.
Required Attributes
- Perform imaging procedures required for each specific study protocol and be certified through the digital imaging reading center.
- Train and certify to perform refraction and vision testing.
- Deliver safe and appropriate patient care in accordance with study protocol, GCP Guidelines and SOPs.
- Perform venipunctures and process samples with training provided.
- Master multiple computer systems including Google, Microsoft Office, Teams and data management.
- Develop and maintain strong relationships with physicians, coworkers and patients.
- Master ophthalmology and retina terminology.
- ICG GCP Training/Certification.
- Certified Ophthalmic Assistant.
- Cooperate with supervisory staff, physicians, peers, external customers and patients in a positive, energetic, 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 timely completion of tasks.
- Strong interpersonal skills including effective listening, clear communication and customer problem resolution.
- Bilingual in Spanish.
- Ophthalmic experience.
- High‑level initiative and critical‑thinking skills.
- College degree preferred with significant relevant experience and/or ophthalmic experience.
- CRA tier III and/or 18 months with prior performance review exceeding expectations.
Preferred Experience
- 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 & Requirements
Prolonged standing and walking, some sitting, talking and hearing both in person and by telephone; use hands to manipulate objects or controls; reach with hands and arms. Regularly required to stoop, kneel, bend, crouch and lift up to 40lbs on occasion. Specific vision abilities 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.