Job Title: Regulatory & Compliance Specialist I

Work Location: Worcester County, Massachusetts

Summary:

This position is responsible for supporting research regulatory affairs and ensuring compliance with federal and state regulations, as well as institutional policies. The role involves managing regulatory submissions, coordinating training, and maintaining documentation for clinical trials across multiple departments.

Responsibilities:

• Gather and triage initial and continuing review submissions for research projects, ensuring timely processing and regulatory consistency.
• Assess regulatory submissions for completeness and compliance with applicable guidelines and policies.
• Track process metrics, monitor investigator responses, and maintain accurate records of regulatory activities.
• Prepare and submit regulatory and compliance documents to appropriate oversight bodies as required.
• Coordinate and facilitate training sessions for the research community on regulatory and compliance topics.
• Support committee communications by compiling data, assisting with report design, and distributing relevant information.
• Maintain and revise procedure manuals and standard operating procedures to reflect current regulatory requirements.
• Handle confidential and sensitive materials with discretion, and manage multiple priorities in a deadline-driven environment.

Qualifications:

• Bachelor's degree in science or a related field.
• 1 to 3 years of experience in research or regulatory/compliance administration.
• Experience handling confidential and sensitive material.
• Strong oral and written communication skills.
• Ability to prioritize tasks and work effectively under pressure in a deadline-driven environment.
• Familiarity with regulatory affairs, IRB processes, research compliance, and clinical trials.
• Knowledge of federal and state regulations related to research administration.

Published Category: Regulatory Affairs