Ora (www.oraclinical.com) is the world’s leading independent ophthalmic drug and device development firm that provides technology-based, concept-to-market services and solutions that accelerate development timelines and improves the scientific quality of clinical research. With over 1,200 ophthalmic clinical trials and consulting projects completed to date, Ora is the preferred ophthalmic drug development partner for many of the world’s largest pharmaceutical companies as well as the smallest and most innovative startups.
Our success is based on a foundation of scientific rigor applied to the drug development process. Ora’s team has created many advanced clinical models and protocols that have been proven to produce high-integrity safety and efficacy data quickly.
This Site Operations Associate will assist in organizing research information for clinical projects, performing administrative aspects of a clinical trial, and ensuring compliance with protocol and overall clinical objectives under the direction and supervision of the Principal Investigator. As a member of the clinical team he/she will rely on instructions and pre-established guidelines to participate in clinical research activities involving human research subjects while working under immediate supervision of a supervisor or manager collecting basic indications of a subject’s health status.
• Maintains protocol compliance during conduct or clinical projects
• Participates in study start-up activities
• Performs patient screening, recruitment, and enrollment
• Performs clinical skills at study visits
• Maintains study documents, including source documentation, Case Report Forms, and regulatory documentation
REQUIRED SKILLS AND ATTRIBUTES:
• Oral Fluency and written competency in Japanese along with familiarity with Japanese culture and ability to travel up to 70%, flexible hours, and weekend availability is required.
• We will train you:
o To understand the protocols in order to collaborate with the Investigator in answering subject’s questions about the informed consent, as well as be able to take and update a subject’s medical and medication history;
o To understand the significance of inclusion and exclusion criteria, understand how to identify and to whom to report an adverse event, and have knowledge of the basic safety tests used in clinical trials;
o To review past/present medical conditions, surgeries, procedures, and concomitant medications;
• Recent grads with Bachelor’s Degree in Nursing or Life Sciences, CNA or Med Tech certification programs will be considered.
• At least 1 year of experience in clinical trials, or equivalent training and work experience is a plus, but not required.
• Excellent communication and organizational skills
Ora is an Equal Opportunity Employer
RECRUITING AGENCIES AND SEARCH FIRMS, PLEASE READ CAREFULLY
Ora maintains preferred vendors for all permanent and temporary recruitment. All resumes submitted by search firms or recruitment professionals to any employee at Ora in any form without a current signed search agreement will be deemed the sole property of Ora and no fee will be paid in the event the candidate is hired by Ora.