RESEARCH PROGRAM COORDINATOR-RIAO

Summary

Under limited supervision, coordinates the RIAO Research Program , including clinical trial regulatory affairs and clinical trial and research data coordination.

Essential Functions include :

Prepares regulatory documents and monitors regulatory activities for assigned clinical trials.

• Prepares protocol for initial and annual IRB (Institutional Review Board); submits protocol revisions and amendments for IRB review; submits Serious Adverse Events reports and Investigational Drug
• Safety Reports to the IRB; maintains IRB correspondence documentation for study sponsor and cooperative group audits.
• Prepares regulatory documentation binders for study monitoring and audits by National Cooperative Groups (NCG) / Pharmaceutical companies / FDA; assists in preparation of patient charts for audits and monitoring visits.
• Prepares initial Informed Patient Consent forms for study participation; prepares form revisions when requested by study sponsor and submits for IRB review.

Manages the day to day regulatory / protocol maintenance operations of the assigned clinical trials.

QUALIFICATIONS / REQUIREMENTS

Basic professional knowledge; equivalent to a Bachelor's degree; working knowledge of theory and practice within a specialized field

Education / Knowledge : Health Science / Public Health or related field.

Experience : 1-3 years