Ophthalmology Clinical Research Coordinator

Clinical Research Coordinator - Newport Beach, CA

Under the direction of the Research Manager and VP, this position facilitates the execution of new
studies and performs consistent and ongoing coordination of ongoing studies and maintenance of open
and closed studies, as applicable. This position arranges and oversees all clinical study activities and
recruits patients for clinical studies. This position works in close coordination with all team Enrolling
Clinical Research Coordinators, Follow-Up Clinical Research Coordinators, Clinical Research Assistants,
Investigators, study monitors/Clinical Research Associates (CRAs), sponsors, Clinical Research
Organizations (CROs) and the Compliance team to carry out the trial, as well as provide guidance on
the administration of the compliance, financial and other related aspects of all ongoing clinical studies.

OPHTHALMOLOGY RESEARCH RESPONSIBILITIES
- Performing procedures including Optical Coherence Tomography (OCT), Fundus photography, Electroretinography, Intraocular Lens Measurements, Amsler grids, and Visual Field Testing, Tonometry, Refractions, Corneal topography, etc.
- Troubleshooting and regular maintenance of all equipment, machines, computers, etc.
- Administering ophthalmic solutions such as artificial tears, anesthetics, dilating solutions, and prescriptions
- Assisting physicians in exams and procedures
- Performing refractions
- Testing near and distance vision, color vision, EOMs, and depth perception

RESEARCH RESPONSIBILITIES
- Coordinates with Principal Investigator (PI) and other research staff to help ensure that clinical research and related activities are performed in accordance with federal regulations and Standard Operating Procedures (SOPs).
- Assists the PI in development of materials and tools necessary to appropriately train research staff involved in the conduct of the study, related to (but not limited to) protocol requirements, schedule of visits, and execution of research procedures.
- Documents date of training and signatures of research staff trained on study specific training log.
- Coordinates and facilitates monitoring and auditing visits.
- Collaborates with PI to respond to any audit findings and implement approved recommendations.
- Attend and participate in investigator meetings, monitoring visits, audits, seminars, and other regional or national meetings as required or requested.
- Collaborates with the PI and Compliance team to prepare Institutional Review Board (IRB) and any other regulatory submission documents as required by the protocol.
- Organizes and maintains filing in all study files, including but not limited to, regulatory binders, study specific source documentation, and other materials.
- Coordinates and attends Site Initiation Visits (SIVs), Interim Monitor Visits (IMVs), and Close Out Visits (COVs).
- Reviews and develops a familiarity with the protocol, e.g., study procedures and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections.
- Works with the PI to develop and implement recruitment strategies in accordance with IRB requirements.
- Conducts or participates in the informed consent process including discussions with research subjects, including answering any questions related to the study. Obtains appropriate signatures and dates on informed consent forms (ICFs) in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
- Creates study specific source documentation templates utilizing the study protocol, study Case Report Form (CRF) or electronic CRF screenshots, SOPs and GDs, and other provided resources prior to the SIV.
- Prepares study subject research binders by gathering, creating, and including necessary forms, logs, and study source document templates to prepare for subject enrollment.
- Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential subject's eligibility or exclusion.
- Registers subjects to the appropriate coordinating center (if multi-site study), such as through the Interactive Web Response System (IWRS).
- Coordinates subject's physical exams with appropriate study investigators and other tests and procedures required by the study protocol.
- Collects data as required by the protocol. Assures timely completion of Case Report Forms.
- Performs specimen processing and shipment of biological specimen duties.
- Perform functions necessary for successful completion of all protocol required visits/procedures such as vital signs, phlebotomy, diagnostic tests, dispensing of investigational product, scheduling, drug accountability/reconciliation and organizational tasks, where appropriate and as delegated by the PI, in accordance with local country requirements and licensures.
- Assists investigators with recording and reporting of adverse events (AEs) and Serous AEs (SAEs) within appropriate timeframes as per the study protocol, IRB, and local regulatory authority guidelines.
- Schedules study participant appointments and serves as the patient liaison to the PI and other participating investigators.
- Performs study visit reminder phone calls to study subjects for upcoming research appointments.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Sound knowledge of medical terminology.
- Sound knowledge of ICH/GCP and Regulatory requirements.
- Knowledge of good clinical practice (GCP), FDA and HIPAA policies and practices.
- Excellent interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors and sponsors.
- Proficient in the use of Microsoft Office and Excel.
- Fluent in spoken and written English language.

MINIMUM REQUIRED EDUCATION, EXPERIENCE AND CERTIFICATIONS
- At least 1 year of experience as an Ophthalmology Technician/Assistant/Technologist (required)
- Certified Ophthalmic Assistant (COA), Certified Ophthalmic Technician (COT), or Certified Ophthalmic Medical Technologist (COMT) (preferred)
- High School diploma
- More than 1 year of CRC experience, preferably working on industry sponsored trials or appropriate internal progression and promotion (preferred)

Medix is acting as an Employment Agency in relation to this vacancy.