RESEARCH PROGRAM COORD-RIAO
LifeBridge Health
- Baltimore, MD
- Permanent
- Full-time
- 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.
- 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