Job Description

Job Description

Job Description

Overview

As a Clinical Research Assistant, you’ll be responsible for completing the certified vision tasks for each study protocol they are assigned to, processing research referrals, printing and mailing informed consents to patients that have been referred to the research department.

As well as any other Research or Clinic tasks and duties as assigned.

Responsibilities

• Adhere to study according to protocol guidelines.
• Complete Best Corrected Visual Acuity (BCVA) assessments timely and in accordance with protocol.
• Reviews and comprehends each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.
• Be familiar and adhere to all federal drug administration, good clinical practice, and office of human subject research regulations and guidelines.
• Communicate with referring physician’s offices in order to obtain data necessary to complete study requirements.
• Attendance of sponsor prequalification visits, monitor visits, study termination visits as applicable.
• Actively recruit and be involved in competitive enrollment.
• Assist physicians in data search and analysis for research studies.
• Always mark charge ticket with the type of study that the patient is enrolled in.
• Responds to data clarification requests in a timely manner.
• Maintains subject screening logs and protocol deviation logs.
• Maintains a spreadsheet tracking updates to database of all subjects referred to research.
• Completes documentation on each study visit that is used to track all study related activities so that time, effort and materials can be accounted for on a monthly basis.
• Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure all protocols are followed and that there is timely documentation and submission of study data.
• Performed unmasked/masked roles as assigned.
• All other duties as assigned

Qualifications

• Experience in back office Ophthalmology required (tester, OA, etc.)
• Ability to adhere to Good Clinical Practices, FDA, HIPPA, IRB regulation, and principal of research design
• Detail oriented, reliable and able to multi-task in a fast-paced, high-volume work environment
• Excellent verbal and written communication skills
• Personable; empathetic with subject's needs and concerns
• Ability to maintain confidentiality and professionalism
• Flexible schedule working Monday-Friday
• Occasional travel to other RCA locations in Metro Valley

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