Research Regulatory Coordinator III

Overview

    Summary 

The Research Regulatory Coordinator III provides administrative support related to the regulatory process of the Research Department. The Regulatory Coordinator III ensures compliance with federal, state and local regulations and sponsor and departmental standard operating procedures. The Regulatory Coordinator III works under the supervision of the regulatory manager and is responsible for the day to day operations of the department. This position requires knowledge of IRB policies and must be able to assist on Investigator Initiated Trials (IIT), Industry Sponsored Trials, Cooperative Group Sponsored Trials and Compassionate (emergency/single patient) Trials. The Regulatory Coordinator III is responsible for demonstrating professional demeanor and maintaining confidentiality in all interactions both with internal and external contacts. Other duties may be performed as assigned. Travel may be required. 

Responsibilities

• Provide administrative support for the regulatory process 
• Assists department in maintaining compliance with research trial guidelines and sponsor trial requirements by keeping documentation up-to-date and notifying staff of any changes. 
• Assists with developing, revising, reporting and maintaining regulatory trial documents as directed by sponsor, government and institution guidelines. 
• Communicates effectively and acts as a liaison between all parties involved in assigned research trials. 
• Records, types and distributes minutes of departmental and committee meetings, as assigned. 
• Obtains and maintains regulatory document and data entry training, as assigned and required by research trial personnel. 
• Completes assigned goals.   

Education

Preferred: College graduate, Bachelor's degree

Minimum: High School Graduate

Experience 

Preferred:  3 years' experience in secretarial or research Administrative position 

Minimum:  2 years' experience in secretarial or research Administrative position 

Licensure, Registration, Certification 

Preferred:  Professional certification encouraged 

Special Skills 

Minimum:  Must be proficient in Microsoft Office Suite, Internet Explorer and general office equipment. Excellent Written, verbal

Training

Preferred: CITI Training, SOCRA/CCRP certified