About The Position
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).
Requirements
- Independent study coordination
- Screening of potential patients for protocol eligibility
- Presenting non-medical trial concepts and details to patients
- 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
- Presenting study information at regular research staff meetings
- Ensuring compliance with FDA and local IRB
- Scheduling patients for research visits and procedures
- Documenting on Case Report Forms (CRFs)
- Maintaining accurate source documents
- Scheduling and participating in monitoring visits
- Assisting with site initiation visits (SIVs)
- Performing close-out visits (COVs)
- Performing auditing activities
- Communicating with sponsors regarding exceptions and protocol clarifications
- Notifying direct supervisor about concerns regarding data quality and study conduct
- Working with a regulatory coordinator or IRB to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters
- Performing regulatory / Institutional Review Board duties
- Performing budgeting duties
- Assisting with patient research billing and reconciliation
- Maintaining research practices using Good Clinical Practice (GCP) guidelines
- Maintaining strict patient confidentiality according to HIPAA regulations and applicable law
- Participating in required training and education programs
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
