Operations Specialist

ePharmaSolutions Cary, NC
Since 1996, Copernicus Group Independent Review Board® (Copernicus IRB) has been the foremost provider of high-quality ethical review services, focused on the protection of human subject research, during all stages of clinical trials. Renowned for the relentless pursuit of efficiency, Copernicus IRB is incomparably organized to meet the demands of the industry and consistently delivers the most streamlined and highest quality review services to its clients.

The IRB Operations Specialist at our Cary, NC location provides customer service to clients and monitors study related information. The Specialist will support the Board and clients by reviewing and preparing materials for review in accordance with company policies and regulatory requirements.

ESSENTIAL DUTIES/RESPONSIBILITIES:

* Ability to maintain and promote positive working relationships with clients (internal and external) by providing timely and professional service to their needs within the scope of company mission and accompanying regulations

* Ability to proofread and detect errors in typing, spelling, grammar, syntax and punctuation

* Ability to read and interpret documents such as protocols for clinical investigations, medical literature, safety rules, operating and maintenance instructions

* Ability to set priorities and manage time effectively

* Accurately and completely enter information in database

* Contribute to a positive, customer-oriented team environment

* Mentor team members by teaching procedures, monitoring and proofing work, and providing constructive feedback as needed or requested

EDUCATION REQUIREMENTS:

* Bachelor's degree or Associate's Degree preferred, or a combination of equivalent education and experience

QUALIFICATIONS/EXPERIENCE:

* 1- 2 years of applicable experience working in a clerical environment where proofing documents and attention to detail were essential elements of the job requirements

* Advanced knowledge of Microsoft Word, Excel, Outlook, Databases and Adobe

* Knowledge of FDA regulations as they relate to research (preferred)

* Experience working with medical terminology (preferred)

* Able to deal effectively with high volumes, rigid deadlines, and frequent changes

WCG is proud to be an equal opportunity employer – Qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, sexual orientation, gender identity, age, marital status, disability, veteran status or any other status protected by law.

This is a full time-nonexempt position

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