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.

• Assists with the implementation of the clinical research agreement, study budget and investigator contract, review and submission; responsible for annual protocol/research agreement renewal coordination.
• Assists physicians with obtaining protocols of interest; prepares and submits site assessment documentation and regulatory package to study sponsors; coordinates and facilitates pre-study, study initiation and study monitoring visits.
• Develops data collection system to provide necessary patient and physician communication, report generation and statistical output; manages and augments system as necessary; inputs information into the database and verifies accuracy.
• Assists Clinical Research Nurses with patient data collection and submits research data to the NCG according to the protocol regulations; assures compliance with standards set by research groups for continued participation

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