Job Description

We are seeking an experienced and detail-oriented Regulatory Coordinator to support regulatory activities for both drug and medical device clinical trials in our cardiology practice network. This role is essential in ensuring that all research is conducted in full compliance with FDA regulations, GCP/ICH guidelines, and institutional policies. The Regulatory Coordinator will manage regulatory submissions, maintain documentation, and serve as a key liaison between study teams, sponsors, IRBs, and regulatory agencies.

Key Responsibilities:

• Prepare, submit, and maintain regulatory documents required for clinical trials involving investigational drugs and medical devices , including:
• Initial IRB submissions
• Protocol amendments
• Continuing reviews
• Investigator brochures
• Informed consent forms
• Device accountability and IDE documentation
• Ensure compliance with applicable regulations including FDA (21 CFR Parts 312 & 812), ICH-GCP, and sponsor requirements for both drug and device studies.
• Coordinate communications with IRBs, sponsors, monitors, and regulatory agencies to ensure timely approvals and regulatory compliance.
• Maintain up-to-date and audit-ready regulatory binders and eRegulatory systems for each clinical study.
• Track submission timelines and approval statuses to prevent lapses in regulatory compliance.
• Support study start-up processes, including site feasibility, regulatory packet completion, and FDA Form 1572 or Device Accountability Logs.
• Prepare for and participate in sponsor monitoring visits, audits, and regulatory inspections.
• Collaborate with clinical research coordinators and investigators to ensure protocol adherence and proper documentation of regulatory activities.
• Monitor and interpret updates to relevant regulatory guidance related to both drug and device research.

Qualifications:

• Bachelor’s degree
• Minimum of 3 years of regulatory experience in a clinical research setting supporting both drug and device trials required.
• Solid understanding of FDA regulations for IND and IDE trials, IRB requirements, and ICH-GCP guidelines.
• Strong organizational skills with meticulous attention to detail.
• Effective written and verbal communication skills.
• Proficiency with IRB submission portals, eRegulatory platforms, and Microsoft Office Suite.
• Ability to manage multiple priorities and deadlines independently in a fast-paced environment.

Job Tags

Similar Jobs