Clinical Trials Regulatory Lead

Brown University Health; Providence (RI); On-site; USD 58,000 - 96,000; Full time

Job summary

Brown University Health is seeking a Regulatory Coordinator to oversee clinical research regulatory requirements for the department and manage regulatory aspects of trials from approval to closure.

The role involves advising staff, collaborating with investigators, and ensuring compliance with sponsor and regulatory guidelines. A Bachelor's degree and 3-5 years of experience in regulatory trial administration are required.

Qualifications

• Bachelor’s degree in health-related or scientific field.
• Knowledge of federal, local and state clinical research guidelines.
• Ability to work independently and make regulatory decisions.

Responsibilities

• Consults with and advises on regulatory documents for clinical trials.
• Acts as regulatory SME through all phases of studies.
• Leads regulatory training and process improvements.
• Coordinates IND/IDE submissions and communications with sponsors and IRB.
• Maintains study-specific regulatory binders and ensures compliance.

Skills

Regulatory knowledge

Regulatory submissions

Independent judgment

Communication skills

Teamwork

Problem solving

Attention to detail

Microsoft Office

SoCRA certification (eligible)

Education

Bachelor’s degree in health-related or scientific field

Tools

Microsoft Office

Job description

Brown University Health is seeking a Regulatory Coordinator to oversee clinical research regulatory requirements for the department and manage regulatory aspects of trials from approval to closure.

The role involves advising staff, collaborating with investigators, and ensuring compliance with sponsor and regulatory guidelines. A Bachelor's degree and 3-5 years of experience in regulatory trial administration are required.