Regulatory Coordinator

Summary: The Regulatory Coordinator performs multiple tasks to meet compliance requirements in research. This position involves overseeing clinical research regulatory requirements and managing clinical trials. Responsibilities include maintaining regulatory integrity from trial submission to closure, advising staff on regulatory issues, and collaborating with investigators.

Responsibilities:

• Consults and provides advice on regulatory documents and processes related to clinical trials.
• Acts as a regulatory subject matter expert throughout clinical studies.
• Mentors clinical research staff, executing new initiatives and process improvements.
• Develops and revises regulatory policies and procedures.
• Prepares and submits clinical research trial packets to the Institutional Review Board including writing a scientific abstract, preparing a consent form, and drafting a lay summary.
• Ensures compliance with ICH-GCP guidelines.
• Drafts and revises departmental regulatory procedures.
• Develops protocols with principal investigators and reviews scientific literature to inform protocols and recommendations.
• Coordinates submission of Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications.
• Prepares regulatory approval applications and responds to stipulations.
• Participates in and conducts Study Initiation Visits and Interim Monitoring Visits.
• Maintains Regulatory Binders including FDA Form 1572 and Financial Disclosure Forms.
• Assists with training of clinical research staff on regulatory protocols.
• Initiates and leads special projects in process improvement and regulatory training.
• Liaises with sponsors, investigators, and team members providing trial information and updates.

BASIC KNOWLEDGE:

• Bachelor's degree in a health-related or scientific field.
• Knowledge of federal, state, and local guidelines for Clinical Research.
• Ability to work independently and make sound judgments on regulatory issues.
• Strong self-starter and interpersonal skills.
• Team-oriented with excellent communication skills.
• Problem-solving and organizational skills.
• Detail-oriented and proficient in Microsoft Office and database applications.

EXPERIENCE:

• 3-5 years in clinical trial administration or relevant clinical development and regulatory experience.
• Understanding of compliance requirements with federal, state, or local regulations.

WORK ENVIRONMENT AND PHYSICAL REQUIREMENTS:

• Sedentary position with some requirement to transport paperwork (up to 10 lbs).
• Bending and stooping for filing paperwork, standing to copy may also be required.

INDEPENDENT ACTION: Requires decision-making regarding regulatory documentation and ability to answer inquiries from researchers, physicians, and external agencies.

SUPERVISORY RESPONSIBILITY: None

Brown University Health is an Equal Opportunity / Affirmative Action employer.