Clinical Research Coordinator II - Heart Institute
Behavioral Health Market Context
Apply Nowvia Medical Hirings - Talent Rush HQ
Qualifications
- •High School Diploma is required
- •2 years of clinical research related experience is required
Responsibilities
- •The Clinical Research Coordinator II works independently providing study coordination including 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 information at regular research staff meetings
- •May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities
- •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 assessing 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 and auditing activities
- •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
- •May coordinate training and education of other personnel
- •May participate in centralized activities such as auditing, Standard Operating Procedure development, etc
- •May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency
- •May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality
- •May identify new research opportunities and present to investigators
- •Participates in required training and education programs
- •22 more items(s)
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