The Clinical Research Coordinator II for the Strategic Initiative and Alliance Development Program will work 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 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. 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).
In addition, the Clinical Research Coordinator II will be responsible for the following:
To perform medical chart review of patients queried by the EIS team to confirm the diagnosis of various cancers
To perform medical chart review of patients queried by the IT team to confirm the diagnosis of
To enter clinical information of cancer patients (demographic, clinical, diagnosis, pathology, tumor stage, course of treatment, adverse event and outcomes) into various cancer databases.
To link the clinical database with tissue and blood samples from pathology.
To be responsible for generating patient reports for basic, translational, or clinical research and grant writing.
To work on IRB and regulatory aspects of the database and patient consent for the database if indicated and biorepository.
Additional Essential duties:
Scheduling of 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.
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 involve 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.
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ACRP/SoCRA (or equivalent) certification preferred
Four (4) years minimum of directly related experience