Research Regulatory Assistant

Summary

The Regulatory Assistant performs multiple tasks in order to meet compliance requirements in research. This position will be assisting in the overseeing of clinical research regulatory requirements for the department. The Regulatory Assistant will provide support in managing clinical trials for the department.

The Regulatory Assistant supports the department and clinical studies through the regulatory portion of the trial submission process to maintaining the regulatory integrity of assigned clinical trials from approval to closure. The Regulatory Assistant works closely with other Regulatory Assistants and Regulatory Coordinators within the department.

Brown University Health employees are expected to successfully role model the organization's values of Compassion, Accountability, Respect, and Excellence as these values guide our everyday actions with patients, customers and one another.

In addition to our values, all employees are expected to demonstrate the core Success Factors which tell us how we work together and how we get things done. The core Success Factors include:

Instill Trust and Value Differences

Patient and Community Focus and Collaborate

Responsibilities

The Regulatory Assistant supports clinical trials in an administrative manner and is responsible for the following duties:* white-space:pre Assist with the preparation and/ or collection of study related research required regulatory documents, including but not limited to:o white-space:pre CVso white-space:pre MLso white-space:pre Financial Disclosure Formso white-space:pre Conflict of Interest Formso white-space:pre FDA 1572o white-space:pre Delegation of Authority/ Staff Signature Logs* white-space:pre May collect signatures to ensure accuracy of study documents* white-space:pre Receives and processes clinical trial external safety reports, including SUSARs* white-space:pre May process and file IRB and RDC approvals; may update the Clinical Trial Management System* white-space:pre May complete minor revisions to clinical trials, such as personnel updates or continuing reviews* white-space:pre May assist with the preparation and and set-up of sponsor visits, such as Monitoring Visits, Site Initiation Visits and Close-Out Visits* white-space:pre Liaises with regulatory staff, sponsors, investigators, and research team members* white-space:pre Participates in Study Initiation Visits and Interim Monitoring Visits* white-space:pre Performs other duties as assigned

Minimum Qualifications

BASIC KNOWLEDGE:* white-space:pre Bachelor's degree in Applied or Life Sciences or related area, including courses in research methodologies and microcomputer systems.In lieu of a bachelor's degree, an additional 2-3 years of experience may be substituted.* white-space:pre Knowledge of theory and techniques of research methodology* white-space:pre Must possess the following skills:o white-space:pre Detail-oriented and excellent organizational skillso white-space:pre Strong-self-startero white-space:pre Interpersonal skillso white-space:pre Team-orientedo white-space:pre Excellent oral and written communication skillso white-space:pre Proficient in Microsoft office and in various database applicationsEXPERIENCE:6 months - 1 year in direct clinical trial administration experience or relevant administrative experience preferred but not required.The Regulatory Assistant should develop general understanding of compliance requirements with federal, state and/or local programmatic regulations within three months of employment.WORK ENVIRONMENT AND PHYSICAL REQUIREMENTS:This position is a sedentary position.

One must be able to transport paperwork to another building (sometimes up to 10 lbs.) at one time. Bending and stooping may also be requirements for filing of paperwork.

Standing to copy may also be required.INDEPENDENT ACTION:This position requires a quick-thinker, who can independently make basic and sometimes complex decisions pertaining to the completion and transmission of required regulatory documentation to internal departments, as well as external agencies, including, but not limited to study sponsors, local and federal agencies.

This person should also be able to work with outside monitors and work independently. He/she should be able answer inquiries related to regulatory issues, and if not known, communicate with the correct person to determine the answer.SUPERVISORY RESPONSIBILITY: None

Pay Range

$41,537.60-$68,556.80