Regulatory Affairs Specialist

Job Title:                  Regulatory Affairs Specialist

Summary:      The Regulatory Affairs Specialist (RAS) performs tasks related to study related regulatory documents, IRB submissions, and other site documentation, including quality control of study documentation. The RAS is responsible for developing and maintaining positive relationships with sponsors as well as internal study teams through oral and written communications regarding submission  requirements, clarification and follow-up of submissions under review. 

EDUCATION, kNOWLEDGE, SKILLS AND ABILITIES:   

The position of Regulatory Affairs Coordinator requires a Bachelor’s degree in science related field. 1-3 years experience in clinical trials as a research assistant, or research coordinator.  Excellent verbal and written communication skills, organizational skills, and interpersonal skills are required.

Responsibilities:

The tasks of the Regulatory Affairs Coordinator include but are not limited to:

  • Receives and inventories project documents including regulatory documents and IRB materials from investigative sites
  • Assists core team members on study teams, providing Regulatory Affairs feedback and guidance throughout the study
  • Processes and routes documents per work instructions
  • Preparation and submission of regulatory documents, as well as internal regulatory file documentation
  • Maintains the security of all documents related to all ongoing study projects as well as archived documents in accordance with Clinilabs’ procedures.
  • Assists in the design of study tracking reports and maintains tracking reports on site document submission
  • Reviewing advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes
  • Gathers information, searches files and records, and communicates with appropriate contacts to obtain specific information necessary to prepare reports and compose routine correspondence
  • Coordinate with Project Manager on monitoring strategy and  monitoring schedule
  • Facilitates communication among personnel associated with projects, resolving and transmitting messages regarding problems, requests for information, and other divisional operations requests.
  • Communicates with investigative site personnel regarding regulatory documents, IRB submissions, and other related documents
  • Attends project team meetings and maintains accurate meeting notes
  • Assists with the coordination of packaging, shipping, and tracking of supplies and materials to investigative sites
  • Schedule and coordinate meetings, both internally and externally
  • Provides clerical support for supervisor, as needed
  • Participate in clinical training programs and maintain awareness of developments in the field of clinical research
  • Support and maintain Quality initiatives in accordance with Clinilabs Quality Policy
  • Continuously assess ways to improve Quality
  • Other duties as required