Site Submissions Specialist

Copernicus Group Independent Review Board - Cary, NC (30+ days ago)


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.

Our Site Submissions Specialist: at our Cary, NC location provides customer service to clients (Principal Investigator’s (PIs), Contract Research Organizations (CROs), Sponsors and sites) while monitoring study related information to ensure proper preparation for board review. Within the scope of this position, contribute to the company’s overall mission to protect the rights and welfare of human subjects involved in clinical research.

ESSENTIAL DUTIES/RESPONSIBILITIES:
Attendance and punctuality are essential functions of the position
Maintain and promote positive working relationships with clients
Review new Principal Investigator Submissions and ensure they are complete and accurate according to internal standards. Monitor required documentation including but not limited to licenses and credentials of new investigators listed on the FDA Form 1572, identifying issues identified and notifying the Chairperson and/or Assistant Director of IRB Services and Study Start Up
Enter new Principal Investigators and new study information into Access database and other Business Systems as designated by the corporation
Notify and record changes in studies, documents, and/or contact info entering changes accurately into Access database and communicating changes to necessary departments in the company
Ensure 100% accuracy in all work performed, including investigator packets and all associated regulatory documents, and understand the importance of accurate information as it pertains to strict confidentiality standards of the company
Work as a team with colleagues to ensure all project team efforts are completed according to company policies and procedures and all departmental goals and objectives are achieved

EDUCATION REQUIREMENTS:
  • Bachelor’s degree or equivalent experience
QUALIFICATIONS/EXPERIENCE:
  • Minimum of 6 months experience in clinical trial setting, review board and/or pharmaceutical industry
  • Knowledge of FDA regulations as they relate to research preferred
  • Must have advanced knowledge of Microsoft Word, Excel, Outlook and Access
  • Attention to detail required in a highly regulated industry
  • Ability to work independently, utilize discretionary judgment, and be a pro-active team player is required
  • Must possess excellent verbal and written communication skills
  • Ability to proofread and detect errors in typing, spelling, grammar, syntax and punctuation required
  • Experience with medical terminology preferred
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.