Clinical Research Coordinator

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 help support our strong research program by providing IP accountability, oversight, and training. This position will also assist and serve as a point of contact between the Austin and Round Rock sites, research team members, monitors and sponsors to facilitate IP accountability.

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
• Ensure study staff are trained on study protocols, ICF, manuals and document all trainings
• Will create, manage and maintain sour document for each assigned trial
• Attend teleconferences and meetings as requested by research director
• Review and understand all study protocols including proceedings, timeline, inclusion/exclusion criteria, confidentiality and privacy protections
• Provide care for study patients during study visits, perform diagnostic testing, schedule appointments and provide education 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 CRO's including data entry queries, audits and monitoring visits
• 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, and ALL adverse and serious adverse events  to be  reported to the sponsor and IRB within the required timeframe
• 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/Supervisor

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

• Master multiple computer systems including Google, MicrosoftOffice, Teams, data management 
• 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, MicrosoftOffice, Teams, data management 
• Ability to develop and maintain strong relationships with physicians, coworkers, and patients 
• Will master ophthalmology and retina terminology
• 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

• 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
• Demonstrates high-level initiative and critical thinking skills 
• College degree preferred, significant relevant experience, and/or Ophthalmic experience
• CRA tier III and/or  3 years with prior performance review or assessment exceeding expectations 
•  ICH GCP Training/Certification
•  IATA Certification
• Real Time

Position Details

• Schedule approximately 8-5pm during weekdays 
• Hourly pay, FLSA non-exempt, eligible for overtime

Benefits! 

In addition to making a difference for our patients, Austin Retina offers amazing benefits to make a difference for our Team including:

• Free HSA Medical Health Plan and 2 Blue Cross/Blue Shield Health Plans with generous employer contributions
• Dental & Vision Insurance
• Company paid life and long term disability insurance
• Employee Assistance Program company paid
• 401k with automatic Employer contributions even if you don't contribute
• Rewards & Recognition program
• Discount gym program
• Fun company events
• Leadership development and Career pathways

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 includes 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.