Analyst-Reg Affairs I

Job Requirements

Position Summary

Responsible for creating, submitting, and filing regulatory documents, including serious adverse events for the Clinical Research Department. Responsible for submitting documents to the IRB and creating and updating informed consents under the direction of the Regulatory Affairs Manager and Clinical Research Director. Assist with CCOP duties as defined by Manager.

Minimum Requirements

Education

• Bachelor's Degree (Can substitute equivalent experience)

Experience

• 1 year in Clinical Research or Regulatory Affairs

License/Registration/Certifications

• RAC, CCRA, CCRP, CCRC, or CIP required within three years of employment

Preferred Requirements

Preferred Education

• N/A

Preferred Experience

• 5-8 years' experience in Clinical Trials or Regulatory Affairs

Preferred License/Registration/Certifications

• N/A

Core Job Responsibilities

Working knowledge of FDA/OPRR/GCP/ICH guidelines

MS office experience

Attention to detail, excellent organizational skills.

Excellent knowledge of medical terminology

Must have knowledge with OHRP guidelines

Must have knowledge of Institutional Review Board guidelines, processes and policies

Experience with FDA documents required

Experience with Informed Consent writing required

Must be meticulous with detail

Physical Requirements

Must be able to withstand the stress and demands of an active position

Must be able to think clearly and quickly in high pressure/high volume environment

Must be able to work as a team member with staff, physicians, managers and Administration

Ability to work other than scheduled hours with little or no notice as needed; ability to work independently with minimal direction and to be able to respond calmly and efficiently in crisis situation.

Possess excellent communication and organizational skills

Must be able to read, write, and speak English fluently; manual dexterity, good eye/hand coordination and adequate vision needed in daily work.