Analyst-Reg Affairs I

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.