Regulatory Affairs Specialist I, II, III - Remote

Overview

The Regulatory Affairs Specialist is responsible for ensuring regulatory compliance and administrative management for multiple clinical trials, collaborating with investigators and sponsors to support clinical research initiatives.

In Short

• Ensure regulatory compliance for clinical trials.
• Work with investigators and sponsors to manage clinical research.
• Organize complex projects and maintain attention to detail.
• Prepare and submit research protocols to IRBs.
• Monitor protocol status and advise on requirements.
• Maintain regulatory documents and study binders.
• Participate in the development of clinical trial management systems.
• Communicate effectively with stakeholders.
• Act as a team leader for special projects when required.
• Contribute to a collaborative health care organization.

Requirements

• Bachelor's degree or equivalent experience required.
• Experience in clinical research preferred.
• Knowledge of federal regulations and guidelines.
• Strong organizational and communication skills.
• Ability to analyze data and prepare high-quality documents.
• Experience with regulatory submissions and compliance.
• Ability to work collaboratively in a team environment.
• Attention to detail and ability to manage multiple projects.
• Proof of legal authority to work in the USA required.
• Pre-employment screening will be conducted.

Benefits

• Health insurance options available.
• Holiday, vacation, and sick leave.
• Education discounts for staff and dependents.
• Retirement plan with up to 10% matching contribution.
• Career training and educational opportunities.
• Merchant discounts available.
• Concierge pharmacy services on campus.
• Supportive work environment focused on teamwork.
• Diversity and inclusion initiatives.
• Opportunities for professional growth.