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.

The Regulatory Assistant supports clinical trials in an administrative manner and is responsible for the following duties:

*Assist with the preparation and/ or collection of study related research required regulatory documents including but not limited to:

oCVs

oMLs

oFinancial Disclosure Forms

oConflict of Interest Forms

oFDA 1572

oDelegation of Authority/ Staff Signature Logs

*May collect signatures to ensure accuracy of study documents

*Receives and processes clinical trial external safety reports including SUSARs

*May process and file IRB and RDC approvals; may update the Clinical Trial Management System

*May complete minor revisions to clinical trials such as personnel updates or continuing reviews

*May assist with the preparation and and set-up of sponsor visits such as Monitoring Visits Site Initiation Visits and Close-Out Visits

*Liaises with regulatory staff sponsors investigators and research team members

*Participates in Study Initiation Visits and Interim Monitoring Visits

*Performs other duties as assigned

BASIC KNOWLEDGE:

*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.

*Knowledge of theory and techniques of research methodology

*Must possess the following skills:

oDetail-oriented and excellent organizational skills

oStrong-self-starter

oInterpersonal skills

oTeam-oriented

oExcellent oral and written communication skills

oProficient in Microsoft office and in various database applications

EXPERIENCE:

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

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