Position Description

The Internal Research Monitor provides support for the Research Compliance Program at Northside Hospital and its affiliates by monitoring clinical trials and following established processes to support compliance with applicable regulations. The Internal Research Monitor conducts a variety of monitoring activities intended to facilitate and assure that clinical trials comply with the requirements of the approved study protocol, the approving Institutional Review Board, Northside Hospital polices and applicable Food and Drug Administration (FDA) and other regulatory requirements.

Position Requirements

REQUIRED:
1. A Bachelor’s degree with a minimum of three (3) years’ experience in a clinical research setting which includes at least one year of monitoring or administering complex clinical trials.

2. A sound knowledge of ICH and Food and Drug Administration’s Good Clinical Practices regulations.

3. Certification as a Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) must be completed within 1 year of hire date.

4. Extensive understanding of human subject protection and Institutional Review Board (IRB) regulation and operation.

5. Effective oral and written communication skills.

6. Experience using Microsoft Office suite programs such as Word, Excel, Power Point etc.

7. Established interpersonal skills combined with the ability to be highly motivated and work independently.

8. Well organized with a high level of attention to detail and able to maintain accurate and complete research records.

9. Ability to correctly interpret laws, regulations and policies related to research compliance.

10. Excellent project management skills with the ability to manage multiple tasks simultaneously.

11. Ability to provide constructive feedback 

12. Demonstrated analytical and problem solving skills

Service Area Overview