Ophthalmic Technician (Clinical Research)

Center for Sight Las Vegas•Las Vegas, NV

12d•Onsite

About The Position

Under the direction of the Clinical Research Manager, this role ensures and assists with the efficient operations of the Clinical Research Department. Key responsibilities include subject recruitment, preparation and scheduling of subject visits, obtaining informed consent, conducting subject visit workups and diagnostic testing, maintaining regulatory and subject binders, managing investigational drug and device accountability, and ensuring adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP). The role also involves correspondence with sponsors and Institutional Review Boards (IRBs).

Requirements

High School Diploma or GED
1-2 years ophthalmic experience
1-2 years clinical research experience
General knowledge of ophthalmology and medical terminology
Completion of Good Clinical Practice training, or working toward such training
Strong computer competency including intermediate knowledge and experience with Excel, Microsoft Office software, data management programs and the ability to easily adapt to new software applications or data management systems.
Ability to maintain strict confidentiality of all subjects and clinical research protocols.
Ability to work well in a team situation.
Ability to adapt to additional assigned roles or alternate site location.
Strong organizational skills with high attention to detail.
Ability to perform accurate documentation within set deadlines.
Ability to seek advice when needed.
Competency in problem solving.
Ability to function as a reliable, punctual, flexible and responsive team member.
Ability to be proactive in problem solving.

Nice To Haves

Some college preferred
Certified Ophthalmic Assistant certification preferred

Responsibilities

Adhere to Occupational Safety and Health Administration (OSHA) and Good Clinical Practice (GCP) guidelines and policies.
Promote safety and confidentiality of clinical research participants at all times.
Adhere to clinical trial protocols, operating policies and procedures.
Perform subject visit preparation including source document and case report form preparation, scheduling study visits per protocol, sending reminders to subjects of their study visits, and ensuring study documents are complete, current, and filed correctly.
Perform subject recruitment and enrollment by identifying potential subjects per eligibility requirements, contacting, scheduling, and screening potential subjects, and managing subject compliance and retention.
Perform subject data maintenance, accountability, and essential functions of subject binders, regulatory binders, subject stipends, data entry into electronic data capture systems (EDC), tracking systems, and data query resolution.
Perform designated protocol functions per study protocols such as dosing instruction, informed consent, subject visit workup (including Refractometry, Pachymetry, EDTRS Visual Acuity, Snellen Visual Acuity, diagnostic testing), and instrument calibration & maintenance.
Maintain study accountability logs, temperature logs, and other essential documents.
Maintain investigational drug and device monitoring, shipments, and accountability.
Interact and communicate effectively and professionally (both verbally and written) with the Clinical Research Manager, Investigators, Administration, all staff, sponsors, monitors, and study participants.
Handle correspondence between sponsors, monitors, Institutional Review Boards (IRB), and the site.
Provide accurate, complete, and timely documentation in accordance with study protocols and Good Clinical Practice guidelines.
Perform additional duties as assigned.