Essential Duties And Responsibilities Include The Following

Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients
Participates in the informed consent process and enrolls patients on protocol.
Coordinates patient care in compliance with protocol requirements.
In collaboration with the physician, reviews patients for changes in condition, adverse events,

concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.

Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities.
Maintains regulatory documents.
Participates in required training and education programs. Responsible for education of clinic staff regarding clinical research.
May oversee the preparation of orders by physicians to assure that protocol compliance is maintained.
Communicates with physician regarding study requirements.
Provides a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards.
Responsible for accurately maintaining and recording Investigational Product receipt from the Sponsor and its use.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Adhere to GCP, ICH, HIPAA, NIH, FDA Regulations and SOPs guidelines
Contribute to growth of company with future supervisory role

Requirements

Education Experience

Job Posted by ApplicantPro

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