Regulatory Coordinator

About the role

Summary: The Regulatory Coordinator performs multiple tasks to meet compliance requirements in research, overseeing clinical research regulatory requirements for the department, providing support in managing clinical trials, maintaining regulatory integrity from approval to closure, instructing and advising staff on regulatory/compliance issues, and collaborating with investigators to resolve regulatory inquiries. Brown University Health employees are expected to role model the organization's values of Compassion, Accountability, Respect, and Excellence, and demonstrate core success factors including Instill Trust, Value Differences, Patient and Community Focus, and Collaborate. Location: CM-Providence-Coastal Medical Corporate Office-10 Davol Square, Providence, RI 02903.

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, including execution of new initiatives and process improvement.
• Develops and/or revises regulatory policies and procedures.
• Initiates and leads special projects, including 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, 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.

Requirements

• Bachelor’s degree in health-related or scientific field.
• Sound knowledge of all federal, local and state guidelines pertaining to Clinical Research.
• Ability to work independently, make sound judgments on regulatory issues.
• Strong self‑starter with interpersonal skills and influence.
• 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.
• Proficiency in various database applications.
• Ability to foster smooth communications and teamwork among clinical research faculty, fellows, staff and external organizations.
• SoCRA certification or eligibility to obtain within 18 months of hire.
• 3‑5 years of direct clinical trial administration experience or relevant clinical development and regulatory experience.
• Understanding of compliance requirements with federal, state or local programmatic regulations.

Pay

$58,489.60‑$96,491.20 (annual)

Schedule

Monday‑Friday, 8:00 am – 4:30 pm (8‑hour day shift). No driving required.