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.
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.