Clinical Research Coordinator I – Medically Associated Science & Technology (MAST) Program
About The Position
The Clinical Research Coordinator I works independently providing study coordination including screening of patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. The incumbent is responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. The CRC I team member is responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. The incumbent presents information at research staff meetings.
Requirements
- Works independently providing study coordination
- Screening of patients for protocol eligibility
- Participating in the informed consent process
- Accurate and timely source documents, data collection, documentation, entry, and reporting
- Timely response to sponsor queries
- Compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information
- Presents information at research staff meetings
- Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
- Participates in required training and education programs.
Nice To Haves
- May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
- May coordinate training and education of other personnel.
Responsibilities
- Schedules patients for research visits and procedures.
- In collaboration with the physician and other medical personnel, documents 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.
- 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 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.
- 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
No Education Listed
