26 days old

Operations Analyst - Site Submissions Team

WIRB-Copernicus Group (WCG)
Cary, NC 27513

General Information

Location: Cary, NC

Organization: Copernicus Group

Job Type: Full Time

Description and Requirements

The Operations Analyst, in our Cary, NC office location, will provide customer service to clients (PIs, CROs, Sponsors and sites) while monitoring study related information to ensure proper preparation for IRB board review.  This role will perform various tasks within the Client Services departments to ensure adequate resource levels for critical work processes.  Within the scope of this position, contribute to the companys overall mission to protect the rights and welfare of human subjects involved in clinical research.


  • Bachelors degree or equivalent experience


  • Minimum of 2 years experience in clinical research setting preferred.

  • Knowledge of FDA regulations as they relate to research strongly preferred. Medical terminology preferred.

  • Must have advanced knowledge of Microsoft Word, Excel, Outlook and Access. 

  • Attention to detail required in a highly regulated industry.

  • Must possess excellent verbal and written communication skills. 

  • Ability to multi-task, work in demanding situations, meet strict deadlines, work independently, utilize discretionary judgment, and be a pro-active team player. 

  • Strong interpersonal skills required, including a focus on problem solving, listening objectively, and contributing to maintaining a positive team spirit. 

  • Ability to proofread and detect errors in typing, spelling, grammar, syntax and punctuation required. 


  • Work with all colleagues in client services teams to ensure work processes are completed according to company policies and procedures and all departmental goals and objectives are achieved.

  • Maintain and promote positive working relationships with clients by providing timely and professional service to their needs within the scope of company mission and accompanying regulations.

  • Ensure 100% accuracy in all work performed in assistance to, including but not limited to, new protocol and investigator, ongoing study management, and safety submissions.

  • Demonstrate competency in processing all types of submissions with minimal errors.

  • Provide excellent customer service to all staff and/or board members for work related inquiries and/or needs.

  • Assist Designated Team with requests for translation of study materials, as needed.

  • Assist Designated Team with uploading and labeling of new submissions, verification of licensure of investigators, data entry of investigator information into Protocol Tracking System, and review and labeling of subject recruitment and support materials.

  • Assist Designated Team with task processing and administrative duties.

  • Provide quality checks for approval documents and informed consent forms.

  • Provide temporary coverage for Designated Points of Contact staff during periods of extended leave or absence. 

  • Assist in the timely entry of safety data as determined by review guidelines and standard department procedures. Review the quality of data entered to ensure study related information is correctly and uniformly entered into the Access database according to company standards.

About Us:

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.


Posted: 2019-08-20 Expires: 2019-09-19

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:

Operations Analyst - Site Submissions Team

WIRB-Copernicus Group (WCG)
Cary, NC 27513

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast