Round Rock -Clinical Research Coordinator I

Austin Retina Associates•Round Rock, TX

2d•Onsite

About The Position

Austin Retina Associates is seeking a responsible, self-motivated individual to provide research coordination in a thriving retina practice’s growing research department. Our goal is to advance retinal research, offer new treatment opportunities to our community, and provide the highest quality patient care. The ideal candidate is passionate about patient care and the administrative aspects of clinical research.

Requirements

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.

Nice To Haves

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.

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.