A regulatory coordinator is typically responsible for all of the regulatory aspects of a company. The coordinator works with various other people, such as research coordinators and principal investigators. The job typically requires a candidate to have a bachelor’s degree, computer literacy, and excellent interpersonal skills. Workers also need to have an excellent understanding of the English language and a minimum of two years working in the health care field or a related industry. A regulatory coordinator must be familiar with procedures and research terminology. The typical regulatory coordinator keeps full-time standard daytime office hours.
Duties of a regulatory coordinator include maintaining regulatory data integrity, assisting in the preparation of FDA or internal audits, functioning as a team player, working effectively with other coordinators in the same department, reviewing all regulatory documents, developing a technique to track study activity, and carrying out work assignments with little supervision and exemplary judgment. This job requires the worker to ensure that important forms are submitted in a timely manner. Some skills that are required from a potential candidate include the ability to work well in a fast-paced environment and maintain good organization and time management. Other various duties include working closely with sponsors and study personnel on pertinent regulatory issues, developing procedures and policies, and leading regulatory educational events in order to fully educate other staff members or colleagues.
Regulatory Coordinator Tasks
Prepare and file various reports, presentations, documents, and permits.
Guarantee compliance with government regulations via research, assessment, and gathering data.
Work with a team to facilitate adherence to guidelines.
Review all protocol and implement improvements continually.
Resolve problems associated with noncompliance.