Clinical Trials Regulatory Assistant

Lifespan; Providence (RI); On-site; USD 41,537 - 68,556; Full time

Job summary

Brown University Health is seeking a Regulatory Assistant to support clinical trial regulatory activities from approval to closure at Rhode Island Hospital. You will help prepare regulatory documents, collect signatures, and handle safety reports within a collaborative team.

The role requires a life sciences background, strong organizational and communication skills, and proficiency with MS Office. The position is based in Providence, RI, with standard work hours.

Qualifications

• Bachelor's degree in Applied or Life Sciences or related area; substitution: 2–3 years of experience may be substituted.
• Knowledge of theory and techniques of research methodology.
• Detail-oriented, organized, self-starter, interpersonal, team-oriented with strong oral and written communication; proficient in MS Office and databases.

Responsibilities

• Assist with the preparation and collection of study-related regulatory documents (CVs, FDA 1572, disclosure forms, etc.).
• May collect signatures to ensure accuracy of study documents.
• Receive and process external safety reports, including SUSARs.
• Process and file IRB and RDC approvals; may update the Clinical Trial Management System.
• Assist with sponsor visits such as Monitoring, Site Initiation and Close-Out Visits.
• Liaise with regulatory staff, sponsors, investigators and the research team.
• Participate in Study Initiation Visits and Interim Monitoring Visits.
• Performs other duties as assigned.

Skills

Detail-oriented

Organizational skills

Self-starter

Interpersonal skills

Team oriented

Communication

Microsoft Office & databases

Education

Bachelor's degree in Applied or Life Sciences or related area

Tools

Microsoft Office

Database applications

Job description

Brown University Health is seeking a Regulatory Assistant to support clinical trial regulatory activities from approval to closure at Rhode Island Hospital. You will help prepare regulatory documents, collect signatures, and handle safety reports within a collaborative team.

The role requires a life sciences background, strong organizational and communication skills, and proficiency with MS Office. The position is based in Providence, RI, with standard work hours.