Clinical Trials Regulatory Lead

Brown Medicine; United States; On-site; USD 58,000 - 96,000; Full time

Job summary

Brown University Health seeks a Regulatory Coordinator to oversee clinical research regulatory requirements for the department, supporting trials from submission through closure and advising staff on compliance issues.

The role involves collaborating with investigators, sponsors and study teams, coordinating IND/IDE submissions, interpreting protocols, and maintaining regulatory binders to ensure adherence to FDA guidelines and sponsor requirements.

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.

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 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. 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.
• Coordinates and facilitates the 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, respond to stipulations, and shepherd 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.

Job description

Brown University Health seeks a Regulatory Coordinator to oversee clinical research regulatory requirements for the department, supporting trials from submission through closure and advising staff on compliance issues.

The role involves collaborating with investigators, sponsors and study teams, coordinating IND/IDE submissions, interpreting protocols, and maintaining regulatory binders to ensure adherence to FDA guidelines and sponsor requirements.