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.
• Collaborates with the physician to review 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 educating clinic staff regarding clinical research.
• May oversee the preparation of orders by physicians to ensure protocol compliance is maintained.
• Communicates with physicians regarding study requirements.
• Ensures 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.
• Adheres to GCP, ICH, HIPAA, NIH, FDA Regulations and SOPs guidelines.
• Contributes to the company's growth with future supervisory roles.

Requirements

• Bilingual English/Spanish
• 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 detail-oriented
• Must be willing to travel to various locations in Greater Houston

Education & Experience

• Bachelor’s degree required, Master’s degree preferred
• Minimum of three years in Clinical Research