Clinical Research Coordinator

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:
• 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 skills
• Proficiency 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