Research Reg Coordinator II
Department: ONC Clinical Research
Status: Full Time
Responsible for coordination of individual research projects.
Prepares an Institutional Review Board (IRB) approved project for patient accrual.
Monitor local Serious Adverse Event (SAE) reports from Clinical Research Coordinators (CRCs) and submit report for IRB review.
Monitor protocol deviations as identified by CRCs and submit report for IRB review.
Monitor data delinquencies as identified by data managers.
Conducts internal audits to monitor protocol compliance and data quality.
Monitor timely submission of screening logs.
Monitor patient accrual. Monitor re-consent process when requested by IRB.
Communicate project status with Principal Investigator.
Submit initial 6-month project report for IRB review. Repeat as directed by IRB.
Monitor community-based projects for protocol compliance and data quality.
Conducts quality assurance activities for department.
Leads the team in presenting professional posters and abstracts.
Assists the education of research staff as it relates to CFR, ICH guidelines and local IRB policies and procedures
Coordinates and assists with external audits and monitor visits.
Liaison between the Principal Investigator, the Sponsor and the IRB.
Responds and resolves queries from the IRB.
Collaborates with other Hospital departments acting as a research regulatory resource.
Maintains reasonably regular, punctual attendance consistent with Orlando Health policies, the ADA, FMLA and other federal, state and local standards.
Maintains compliance with all Orlando Health policies and procedures.
Other Related Functions
Attends appropriate departmental meetings.
Attends regulatory meetings as required.
Demonstrates expertise of computer software specific to department.
Associates degree with four (4) years experience in research OR;
Bachelors degree with two (2) years experience in research.
Certified Clinical Research Professional (SoCRA) OR Certified IRB Professional (PRIM&R), OR Certified Clinical Research Coordinator (ACRP)
Four (4) years experience in clinical research with Associates degree OR
Two (2) years clinical research with a Bachelors degree in health or research-related field.
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