San Marcos-Clinical Research Coordinator

Clinical Research Coordinator I

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
• 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 time frames
• 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

• 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 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

• 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…