Regulatory Coordinator

3 weeks ago


Selma, United States Infirmary Health Full time
Overview

Qualifications

Minimum Qualifications

Associate degree in Clinical Research or related OR 3 years direct clinical research-related experience within the last 5 years

Must have:
  • Problem solving, analytical, resource management, and creative thinking skills
  • Ability to plan and schedule tasks and projects and complete them in a timely manner
  • Ability to delegate duties while maintaining responsibility for completion of tasks
Ability to maintain confidentiality of sensitive information

Licensure, Registration, Certification

Certified Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SOCRA) certification

If not currently certified in CCRC, certification must be obtained within 12 months of qualification for exam

Desired Qualifications

Bachelor's degree

Understanding of:
  • Good Clinical Practice (GCPs) and all regulatory requirements of the FDA
  • Microsoft Office Suite, research specific software, and other general office equipment


Licensure, Registration, Certification

Regulatory Affairs Certification (RAC) through Regulatory Affairs Professionals Society (RAPS)/ Certified IRB Professional (CIP) certification

Responsibilities

The Coordinator Regulatory (RC) is responsible for coordinating activities related to the submission and maintenance of regulatory files, preparation of informed consent forms, study summaries, and IRB submissions. Works closely with research staff on various screening and data reports. Ensures compliance with Institutional, IRB, FDA, and sponsor guidelines/regulations and standard operating procedure requirements. The CR is also responsible for demonstrating professional demeanor and maintaining confidentiality in all interactions with both internal and external contacts.

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