Austin Retina Associates · 2 weeks ago
San Marcos-Clinical Research Coordinator I
San Marcos, TX
Full-time
Onsite
New Grad, Entry LevelAustin Retina Associates is seeking a responsible, self-motivated individual to provide research coordination in a thriving retina practice’s growing research department. The role involves facilitating daily clinical trial activities, ensuring study staff are trained, and providing care for study patients during visits.
Health CareMedicalProfessional ServicesService Industry
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
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 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
Qualification
Required
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 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
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
Preferred
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
Company
Austin Retina Associates
Austin Retina Associates delivers excellence in retina care services.
Founded in 1978
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Stephanie Collins, MBA
Chief Executive Officer
Robert Wong
Vitreoretinal Surgeon, Partner
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