27 days old

IRB Operation Specialist 1

WIRB-Copernicus Group (WCG)

General Information

Location: Cary, NC

Organization: WCG IRB

Job Type: Full Time - Regular

Description and Requirements

Our Document Specialist are responsible for processing clinical study research documents and prepare them for regulatory review, while utilizing our proprietary software program. This is a production position; speed and accuracy are important to our clients.  Over time you will have the opportunity to rotate between various functions and gain new skills and increase your pay!  If youre looking for a position where you can contribute using your administrative and database skills, this role might be right for you. This position is internally called an IRB Operations Specialist

Why are we hiring?

The clinical research industry is always growing, especially during the COVID pandemic!  We are hiring more members to join our operations teams in order to help our clients with their clinical research studies. 


To be considered for U.S.-based positions unless currently employed by WCG, where permitted by applicable law (including any applicable reasonable accommodation, medical or religious exemption), candidates must have received or be willing to receive the COVID-19 vaccine by start date.

Essential Duties/Responsibilities:

  • The primary responsibility will be to collect, revise, and process clinical trial and protocol documents in preparation for our boards review.
  • Ensure documents and electronic files are processed while complying with the companys and FDAs formatting and regulatory standards. 
  • Enter data into our proprietary software.
  • Work effectively in a queue with high volumes and frequent changes, all while meeting rigid deadlines.
  • Maintain both speed and accuracy requirements.
  • Overtime is often required in order to meet deadlines and to help clinical trial participants.  We estimate 0-10 hours of overtime weekly, depending on company needs.  50-hour work weeks are common as you progress in your training.

What this job is not:

We are not editors.  Our review process is focused on the content of the clinical study, which is submitted to us by our clients.

Education Requirements:

  • HS Diploma is required  
  • College Graduates are encouraged to apply. 


  • Bachelors degree or two+ years of office experience where proofing documents and attention to detail were essential elements of your job requirements.
  • Intermediate skills with Microsoft Word and Microsoft Outlook.
  • A background in utilizing specialized database systems to process work is strongly desired.
  • Ability to quickly proofread and detect errors in formatting. 

General overview of benefits:

  • Competitive salary
  • Robust medical, dental and vision plans - within 30 days of your employment.
  • 20 PTO days to start and 11 paid holidays annually
  • Matching 401K program
  • Tuition reimbursement
  • More!!!
For over 50 years, WCG IRB has been at the forefront of protecting the rights and welfare of human research participants during all phases of clinical trials.  Recognized as the gold standard of human subject protection, WCG is the trusted partner to over 1,000 institutions in the United States alone, ranging from small community hospitals and research sites to large academic medical centers and universities. Our unparalleled review ensures that human research studies withstand scrutiny around the world.

Posted: 2021-09-21 Expires: 2021-10-22

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

IRB Operation Specialist 1

WIRB-Copernicus Group (WCG)

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast