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