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RESEARCH PROGRAM COORDINATOR-RIAOFacility SINAI-HOSPITAL • Baltimore, MD, US
RESEARCH PROGRAM COORDINATOR-RIAO

RESEARCH PROGRAM COORDINATOR-RIAO

Facility SINAI-HOSPITAL • Baltimore, MD, US
30+ days ago
Job type
  • Full-time
Job description

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

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RESEARCH PROGRAM COORDINATOR-RIAO • Baltimore, MD, US

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