RESEARCH PROGRAM COORDINATOR-RIAOFacility SINAI-HOSPITAL • Baltimore, MD, US
RESEARCH PROGRAM COORDINATOR-RIAO
Facility SINAI-HOSPITAL • Baltimore, MD, US
[job_card.30_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]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
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
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