Regulatory Specialist - Remote

Overview

The Regulatory Specialist will oversee all details of regulatory for assigned trials, ensuring compliance with regulations and supporting start-up activities for all sites and studies.

In Short

• Track essential documents and timelines.
• Handle submissions to the IRB and manage essential regulatory documents.
• Maintain centralized document storage.
• Ensure quality in investigator site files for assigned studies.
• Support sites through evaluation and start-up activities.
• Assist with audits and monitoring visits for regulatory compliance.
• Oversee activities throughout the study duration.
• Liaise with stakeholders to communicate needs and establish timelines.
• Work on new initiatives and projects for departmental growth.
• Display integrity and professionalism in all duties.

Requirements

• Ability to communicate effectively with a diverse team.
• Strong organizational skills and ability to prioritize tasks.
• Excellent verbal and written communication skills.
• Collaborative team player with a positive attitude.
• Strong computer skills, particularly in clinical trials databases and MS Office.
• Critical thinking and problem-solving abilities.
• High level of self-motivation and energy.
• Ability to work independently in a fast-paced environment.
• Client service mentality.
• Bachelor’s Degree or relevant work experience.

Benefits

• PTO/vacation days, sick days, holidays.
• 100% paid medical, dental, and vision insurance; 75% for dependents.
• HSA plan.
• Short-term and long-term disability, and life insurance.
• Culture of growth and equality.
• 401k retirement plan.