Clinical Research Coordinator I - Karsh Division of Gastroenterology and Hepatology
About The Position
The Clinical Research Coordinator I will work independently providing study coordination including screening of research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. The incumbent will be responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. This position presents this information at research staff meetings and ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Requirements
- High School Diploma/GED is required.
- One year of clinical research related experience is required.
Nice To Haves
- Bachelor's or Master's degree is preferred.
Responsibilities
- Schedules research visits and procedures for enrolled participants.
- In collaboration with the physician and other medical personnel, documents completely on Case Report Forms (CRFs) the following; changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
- Maintains accurate source documents related to all research procedures.
- Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information.
- Notifies direct supervisor about concerns regarding data quality and study conduct.
- Schedules and participates in monitoring and auditing activities.
- 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.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
