Regulatory Coordinator

Responsibilities

• Consults with and/or provides advice regarding regulatory documents and/or processes related to clinical trials conduct.
• Serves as the regulatory subject matter expert through all phases of a clinical study.
• Serves as a lead and mentor to other clinical research staff, to include the execution of new initiatives and process improvement.
• Develops and/or revises regulatory policies and procedures.
• Preparing and submitting clinical research trial packets to the Institutional Review Board. Performance of this duty requires the Regulatory Coordinator to write a scientific (technical) abstract of the research project, prepare a consent form and draft a lay summary of the project in terms understandable to a non-scientist.
• Ensuring proper regulatory compliance in accordance with ICH-GCP guidelines.
• Drafting and revising departmental regulatory procedures.
• Developing protocols with principal investigators and providing recommendations on research plans relating to drugs, devices, and medical procedures, which entails reviewing and understanding scientific literature and incorporating that information into the written protocols and recommendations.
• Coordinating submission of Investigational New Drug and Investigational Device Exemption applications.
• Preparing regulatory approval applications and responding to stipulations to ensure approvals.
• Participating in and conducting Study Initiation Visits and Interim Monitoring Visits.
• Reviewing and maintaining Regulatory Binders (FDA Form 1572, Financial Disclosure Form, CLIA, CAP).
• Assisting with training of clinical research staff on regulatory protocols of various clinical trials.
• Serves as the departmental regulatory expert through all phases of clinical trials.
• Initiates and leads special projects, to include process improvement and regulatory training.
• Ensures proper regulatory compliance in accordance with sponsoring agency requirements.
• Liaises with sponsors, investigators, and team members, providing trial information and updates as required in written, oral, and meeting format, adhering to appropriate timelines.
• Develops protocols with the Principal Investigator and provides recommendations on research plan.
• Covers submission of Investigational New Drug (IND) and/or Investigational Device Exemption (IDE) applications.
• In collaboration with the Principal Investigator, interprets protocols and creates consent documents needed for clinical research study.
• Prepares regulatory approval applications, responds to stipulations, and shepherds applications and correspondence through the processes until approvals are obtained.
• Participates in Study Initiation Visits and Interim Monitoring Visits.
• Maintains study-specific regulatory binder.
• Performs other duties as assigned.

Qualifications

• Bachelor’s degree in health-related or scientific field, is required.
• Sound knowledge of all federal, local, and state guidelines pertaining to Clinical Research.
• Must be an independent person, who is capable of making sound judgment pertaining to regulatory issues and have the ability to work independently within the scope of the job requirements.
• Strong self-starter, interpersonal skills, and influence are necessary.
• Team-oriented with excellent oral and written communication skills.
• Strong problem-solving skills.
• Excellent self-management and organizational skills.
• Detail-oriented.
• Computer skills in Microsoft Office.
• Comprehensive knowledge of FDA guidelines.
• Must be proficient in various database applications.
• Ability to foster smooth communications and teamwork among clinical research faculty, fellows, and staff as well as external organizations necessary.
• SoCRA (Society of Clinical Research Associates) certified or eligible within 18 months of hire.
• 3-5 years in direct clinical trial administration experience or relevant clinical development and regulatory experience.
• Understanding of compliance requirements with federal, state, or local programmatic regulations are necessary.