Clinical Research Coordinator - Kidney Transplant
Behavioral Health Market Context
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Qualifications
- •High School Diploma/GED, required
- •1 year Clinical research related experience required
Responsibilities
- •The Clinical Research Coordinator I works independently providing study coordination, screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process
- •Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries
- •Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information
- •Presents study information at regular research staff meetings
- •Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB)
- •Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process
- •Schedules patients for research visits and procedures
- •In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug
- •Maintains accurate source documents related to all research procedures
- •Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries
- •Schedules and participates in monitoring visits, aid in site initiation visits (SIVs), perform close-out visits (COVs), and auditing activities
- •Communicate with sponsors regarding exceptions and protocol clarifications
- •Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings
- •Notifies direct supervisor about concerns regarding data quality and study conduct
- •Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines
- •May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation
- •Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board
- •Maintains research practices using Good Clinical Practice (GCP) guidelines
- •Maintains strict patient confidentiality according to HIPAA regulations and applicable law
- •Participates in required training and education programs
- •17 more items(s)
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