Clinical Research Coordinator

ESSENTIAL DUTIES AND RESPONSIBILITIES

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

Great at customer service Self-motivated/starter Outgoing, excellent recruiting skills Phlebotomy experiences a MUST. CCRC certification a PLUS. Concrete background in medicine Thorough knowledge of medical research Excellent verbal and written communication skillsProficiency with computers, especially Microsoft office Knowledgeable about ICH Guidelines, GCPs, as well as FDA regulations Able to handle multiple protocols in various therapeutic areas Must be detailed oriented Must be willing to travel to various locations in Greater Houston

EDUCATION EXPERIENCE

Bachelors required, Master degree preferred. Minimum of three years in Clinical Research #J-18808-Ljbffr aQua Dialysis