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Research Reg Coordinator II Med Ed Clinical Research

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Company :
Orlando Health

Location :
Orlando, Florida

Expiry Date :
Wed, 16 Dec 2020 23:59:59 GMT

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Description :
Research Reg Coordinator II – Med Ed Clinical Research – Orlando Health Corporate Medical Education Team for Clinical Research is seeking a Research Regulatory Coordinator II who will be responsible for coordination of individual research projects. Education * Associates degree with four (4) years experience in research OR; * Bachelor s degree with two (2) years experience in research. Licensure/Certification * Certified Clinical Research Professional (SoCRA) * or;Certified IRB Professional (PRIM&R) * or; Certified Clinical Research Coordinator (ACRP) Experience * Four (4) years experience in clinical research with Associates degre OR * Two (2) years clinical research with a Bachelor s degree in health or research-related field. Essential_Functions * 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 (CRC s) and submit report for IRB review. * Monitor protocol deviations as identified by CRC s and submit report for IRB review. * Monitor data delinquencies as identified by data managers. * Perform 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. * Assists with quality assurance activities for department. * Able to maintain reasonably regular, punctual attendance consistent with Orlando Health policies, the ADA, FMLA and other * federal, state and local standards. * Able to maintain compliance with all Orlando Health policies and procedures. * 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. Orlando Health is one of Florida s most comprehensive private, not-for-prof healthcare systems providing access to nearly two million Central Florida residents and has provided care for more than 4,600 international visitors annually. Our physician practices, diagnostic centers, hospitals and advanced medical treatments and procedures, along with our highly qualified team of medical specialists, have distinguished Orlando Health as a healthcare leader. We are one of Central Florida s largest employers with more than 15,000 employees and nearly 3,000 affiliated physicians supporting our philosophy of providing a continuum of care that revolves around patients needs. As a leading healthcare resource, providing world-class medical care as well as training our future healthcare providers, Orlando Health will continue to foster growth and development throughout the region for generations to come. We are looking for talented individuals to be part of our team. Show moreShow less