Analyst-Reg Affairs I

Spartanburg Regional Healthcare System • Greer, SC

8d

About The Position

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

Requirements

• Bachelor's degree, or equivalent experience in place of the degree.
• One year of experience in Clinical Research or Regulatory Affairs.
• Must obtain RAC, CCRA, CCRP, CCRC, or CIP certification within three years of employment.
• Working knowledge of FDA, OPRR, GCP, and ICH guidelines.
• Experience with MS Office.
• Attention to detail and excellent organizational skills.
• Excellent knowledge of medical terminology.
• Knowledge of OHRP guidelines.
• Knowledge of Institutional Review Board guidelines, processes, and policies.
• Experience with FDA documents.
• Experience writing informed consents.
• Ability to withstand the stress and demands of an active position and think clearly and quickly in a high-pressure, high-volume environment.
• Ability to work as a team member with staff, physicians, managers, and Administration.
• Ability to work outside scheduled hours with little or no notice as needed, work independently with minimal direction, and respond calmly and efficiently in a crisis situation.
• Excellent communication and organizational skills.
• Ability to read, write, and speak English fluently; manual dexterity, good eye/hand coordination, and adequate vision for daily work.

Nice To Haves

• Five to eight years of experience in Clinical Trials or Regulatory Affairs.

Responsibilities

• Create, submit, and file regulatory documents, including serious adverse events, for the Clinical Research Department.
• Submit documents to the IRB.
• Create and update informed consents under the direction of the Regulatory Affairs Manager and Clinical Research Director.
• Assist with CCOP duties as defined by the Manager.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level